US20120290001A1 - Apparatus and methods for sealing a vascular puncture - Google Patents
Apparatus and methods for sealing a vascular puncture Download PDFInfo
- Publication number
- US20120290001A1 US20120290001A1 US13/105,822 US201113105822A US2012290001A1 US 20120290001 A1 US20120290001 A1 US 20120290001A1 US 201113105822 A US201113105822 A US 201113105822A US 2012290001 A1 US2012290001 A1 US 2012290001A1
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- United States
- Prior art keywords
- tubular member
- distal
- introducer sheath
- cartridge
- distal end
- Prior art date
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Classifications
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
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- A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
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- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00646—Type of implements
- A61B2017/0065—Type of implements the implement being an adhesive
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- A—HUMAN NECESSITIES
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- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00646—Type of implements
- A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
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- A—HUMAN NECESSITIES
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- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00778—Operations on blood vessels
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- A—HUMAN NECESSITIES
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- A61B2017/00831—Material properties
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Definitions
- the present invention relates generally to apparatus and methods for sealing punctures in a body, and more particularly, to apparatus and methods for sealing a vascular puncture extending through tissue into a blood vessel, and to apparatus and methods for delivering a plug, sealant, and/or other material into a percutaneous puncture extending from a patient's skin to a blood vessel or other body lumen, e.g., to seal the puncture.
- Apparatus and methods are known for accessing a patient's vasculature percutaneously, e.g., to perform a procedure within the vasculature, and for sealing the puncture that results after completing the procedure.
- a hollow needle may be inserted through a patient's skin and overlying tissue into a blood vessel.
- a guide wire may be passed through the needle lumen into the blood vessel, whereupon the needle may be removed.
- An introducer sheath may then be advanced over the guide wire into the vessel, e.g., in conjunction with or subsequent to one or more dilators.
- a catheter or other device may be advanced through the introducer sheath and over the guide wire into a position for performing a medical procedure.
- the introducer sheath may facilitate accessing and/or introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss.
- the device(s) and introducer sheath may be removed, leaving a puncture extending between the skin and the vessel wall.
- U.S. Pat. No. 5,108,421 to Fowler discloses a plug that may be delivered into a puncture through tissue.
- U.S. Pat. Nos. 5,192,302 and 5,222,974 issued to Kensey et al. describe a bioabsorbable collagen plug that may be delivered through an introducer sheath into a puncture site.
- the disclosed plug may be difficult to position properly with respect to the vessel, which may be significant since it is generally undesirable to expose the collagen material within the bloodstream where it may float downstream and cause an embolism.
- U.S. Pat. No. 6,605,294 describes rods, plugs, and crushed or irregularly shaped pieces of substantially dehydrated hydrogel that may be introduced into a lumen or void in a patient's body, e.g., to seal or plug a biopsy needle track, reinforce weak tissue, or deliver a therapeutic compound.
- a plug of dehydrated hydrogel may be deployed into the site of an arteriotomy and allowed to hydrate in the presence of the tissue fluids and blood, to fill the tract of the catheter sheath and prevent further bleeding. By swelling to equilibrium hydration, the plug may lock itself firmly in place and thus reduce the risk of formation of a large hematoma at the site of the puncture.
- U.S. Pat. No. 6,703,047 discloses dehydrated hydrogel precursor-based, tissue adherent compositions.
- the hydrogels may be used, for example, for sealing fluid leaks from tissue, as adherent drug delivery depots, and as means for augmenting and/or supporting tissue.
- the hydrogels may be administered directly to an open wound site or may be dispensed, e.g., using a non-adhesive backing material, an absorbable backing material, a syringe applicator, a powder atomization or aerosolization system, or a needle-less injector.
- the present invention is directed to apparatus and methods for sealing a puncture in a body, and, more particularly, to apparatus and methods for providing temporary or permanent hemostasis within a vascular puncture extending into a blood vessel, and/or to apparatus and methods for delivering a sealant and/or other material into a percutaneous puncture extending from a patient's skin to a blood vessel or other body lumen.
- an apparatus for sealing a puncture extending through tissue having an introducer sheath therein that includes a proximal end including a hub, a distal end, and a lumen extending therebetween.
- the apparatus includes an elongate positioning member including a housing on a proximal end thereof, and an expandable positioning element on a distal end thereof, and a cartridge advanceable along the positioning member from a proximal position adjacent the housing to a distal position.
- the cartridge may include a tubular member, a sealant disposed within a lumen of the tubular member, e.g., adjacent the tubular member distal end, and an advancer member disposed within the tubular member lumen adjacent the sealant, e.g., for exposing the sealant from the tubular member lumen when the tubular member is retracted proximally relative to the advancer member.
- the cartridge includes a sleeve slidably disposed over the tubular member distal end, e.g., covering a slitted distal tip of the tubular member.
- the sleeve may include an inner surface configured to provide preferential or different frictional interference with an outer surface of the tubular member, e.g., to allow proximal movement and resist distal movement of the sleeve over the tubular member.
- At least a portion of the sleeve may be sized to abut the introducer sheath hub such that, when the tubular member is advanced from the proximal position to the distal position, the tubular member distal end enters the introducer sheath lumen while the sleeve is stopped by the introducer sheath hub and slides over the tubular member to expose the tubular member distal end within the introducer sheath lumen.
- the sleeve may include a distal portion sized to enter the introducer sheath hub when the cartridge is advanced towards the distal position and a proximal portion that abuts the introducer sheath hub to prevent the entire sleeve from entering the introducer sheath lumen.
- the introducer sheath hub may include a valve therein, and the sleeve distal portion may at least partially open the valve when the cartridge is advanced towards the distal position, e.g., to facilitate the tubular member distal end entering the introducer sheath lumen.
- the positioning member and/or cartridge may include one or more features that limit distal movement of the tubular member when the cartridge is advanced from the proximal position to the distal position.
- features may be provided on the positioning member to prevent further distal movement of the tubular member when the tubular member distal end is spaced a predetermined distance from the positioning element.
- a system for sealing a puncture through tissue that generally includes an introducer sheath, a positioning member, and a cartridge.
- the introducer sheath may include a proximal end including a hub, a distal end sized for introduction into a puncture, and a lumen extending therebetween.
- the positioning member may include an elongate member including a housing on a proximal end thereof and an expandable positioning element on a distal end thereof.
- the cartridge may be advanceable along the positioning member from a proximal position to a distal position, and may include a tubular member including a sealant and an advancer member disposed within lumen of the tubular member.
- a sleeve is slidably disposed over the tubular member distal end such that, when the tubular member is advanced over the positioning member after introducing the positioning element through the introducer sheath, the tubular member distal end enters the introducer sheath lumen while the sleeve is stopped by the introducer sheath hub and slides over the tubular member to expose the tubular member distal end within the introducer sheath lumen.
- a method for sealing a puncture extending through tissue to a body lumen, the puncture having an introducer sheath therein.
- An apparatus may be provided including an elongate positioning member including proximal and distal ends, a cartridge slidable on the positioning member and carrying a sealant therein, and a slidable sleeve located over a distal end of the cartridge.
- the distal end of the positioning member may be introduced through a lumen of the introducer sheath until a positioning element thereon is disposed within the body lumen.
- the positioning element may be expanded within the body lumen, and the positioning member may be refracted until the expanded positioning element contacts a wall of the body lumen.
- the cartridge may be advanced over the positioning member, e.g., until the sleeve on the cartridge contacts a proximal end of the introducer sheath.
- the cartridge may be advanced further, e.g., as one substantially continuous movement, such that the cartridge distal end enters the introducer sheath lumen while the sleeve is stopped by the introducer sheath.
- the sleeve may slide over the cartridge to expose the cartridge distal end within the introducer sheath lumen, e.g., until a distal position is attained.
- the introducer sheath and cartridge may then be at least partially retracted from the puncture, thereby exposing the sealant within the puncture distally beyond the introducer sheath.
- the expanded positioning element may then be collapsed, and the positioning member withdrawn from the puncture, e.g., leaving the sealant within the puncture.
- the cartridge may include an advancer member adjacent the sealant that remains within the puncture when the introducer sheath and cartridge are retracted.
- the positioning member may be withdrawn through the sealant and advancer member.
- the advancer member may be held substantially stationary while the positioning member is withdrawn from the puncture to prevent substantial proximal movement of the sealant.
- the advancer member may be advanced to compress the sealant within the puncture, e.g., before or after withdrawing the positioning member. The advancer member may then be withdrawn, leaving the sealant within the puncture.
- FIGS. 1A and 1B are side and perspective views, respectively, of an exemplary embodiment of an apparatus for delivering a sealant into a puncture through tissue, including a positioning member, and a cartridge movable over the positioning member that includes the sealant and a slidable sleeve.
- FIG. 2A is a partial cross-section of the apparatus of FIGS. 1A and 1B before the slidable sleeve is directed over a distal end of the cartridge.
- FIG. 2B is a cross-sectional detail of the sleeve of FIG. 2A .
- FIGS. 3A and 3B are side views of the apparatus of FIGS. 1A and 1B with the positioning member inserted into an introducer sheath, showing the cartridge in proximal and distal positions, proximally.
- FIGS. 4A and 4B are cross-sectional views of a housing on the cartridge of the apparatus of FIGS. 3A and 3B , with the cartridge in proximal and distal positions, respectively.
- FIGS. 5A-5D are cross-sectional views of a patient's body, showing a method for sealing a puncture extending from a patient's skin to a blood vessel using the apparatus of FIGS. 1A and 1B .
- FIGS. 1A and 1B show an exemplary embodiment of an apparatus 10 for sealing a puncture through tissue.
- the apparatus 10 includes a positioning member 14 and a cartridge 16 carried on the positioning member 14 for delivering a sealant 2 therein into a puncture (not shown).
- the apparatus 10 may be part of a system, e.g., which may also include a delivery, access, procedure, introducer, or other sheath 80 .
- the apparatus 10 and/or system may include one or more other components, e.g., a needle, guidewire, and/or other instrument for creating a puncture (not shown), and/or a source of additional sealing compound (also not shown).
- the cartridge 16 includes an elongate tubular member 20 carrying the sealant 2 therein, an advancer member 30 adjacent the sealant 2 , and a slidable sleeve or cover 50 , as described further below.
- the tubular member 20 includes a proximal end 22 , a distal end 24 sized for introduction into an introducer sheath and/or puncture (not shown), and a lumen 26 extending between the proximal and distal ends 22 , 24 .
- the tubular member 20 may be substantially rigid, semi-rigid, or flexible, e.g., such that the tubular member 20 may be advanced through an introducer sheath or otherwise into a puncture through tissue.
- a handle or hub 23 may be provided on the proximal end 22 , e.g., for releasably coupling the cartridge 16 to the positioning member 14 , as best seen in FIGS. 4A and 4B and described further below.
- a distal tip 25 of the tubular member 20 may be split, e.g., including one or more slits or other features 27 , e.g., to facilitate exposing the sealant 2 from the cartridge 16 .
- a split distal tip 25 may facilitate retraction of the tubular member 20 relative to the sealant 2 , e.g., by providing extra flexibility at the distal end 24 and/or allowing the distal end 24 to expand or otherwise open slightly.
- the slits 27 may accommodate slight expansion of the sealant 2 before being exposed from the tubular member 20 .
- a distal surface of the sealant 2 may be exposed to bodily fluids when the cartridge 16 is advanced into a puncture, which may hydrate and cause the distal end of the sealant 2 to expand slightly.
- the distal end 24 of the tubular member 20 may be exposed to water or other fluid before use of the apparatus 10 , e.g., to partially hydrate the distal end of the sealant 2 and cause the distal end to expand slightly.
- the slits 27 may allow the distal end 24 of the tubular member 20 to open to accommodate such expansion. Otherwise, if the sealant 2 hydrates and/or otherwise expands within the tubular member 20 , the sealant 2 may impose radially outward forces, which may hinder retracting the tubular member 20 to expose the sealant 2 .
- a single longitudinal slit 27 is cut or otherwise formed on one side of the distal tip 25 that extends proximally from the distal tip 25 , e.g., about ten to twenty millimeters (10-20 mm).
- a pair of slits may be provided, e.g., on opposite sides of the distal tip 25 or more than two slits may be provided, if desired (not shown).
- the length of the slit(s) may be less than, substantially equal to, or longer than the length of the sealant 2 , e.g., to reduce the risk of jamming if the sealant 2 begins to expand within the distal tip 25 , as described elsewhere herein.
- a slit that is longer than the sealant 2 may provide hydraulic benefits, e.g., when the cartridge 16 is advanced to introduce the sealant 2 into a puncture.
- fluid inside the introducer sheath may be displaced distally by the cartridge 16 , which may increase pressure at the distal end 24 of the tubular member 20 and/or introducer sheath.
- This increased hydraulic pressure at the distal end 24 of the tubular member 20 may also transmit along the sides of the cartridge 16 , e.g., if there is a gap between the inner diameter of the introducer sheath and the outer diameter of the tubular member 20 .
- a longer slit 27 may allow some relief of this pressure, e.g., by blood or other fluid within the introducer sheath flowing in directly behind the sealant 2 within the lumen 26 of the tubular member 20 and/or otherwise within the cartridge 16 .
- Such infusion behind the sealant 2 may also have the benefit of pre-hydrating the sealant 2 , which may enhance the ability of the sealant 2 to expand quickly when deployed within a puncture or otherwise within the patient's body.
- the advancer member 30 may be an elongate tubular body, e.g., a plunger or catheter, including a proximal end 32 , a distal end 34 sized for introduction into the lumen 26 of the tubular member 20 , and a lumen 36 extending between the proximal and distal ends 32 , 34 .
- the advancer member 30 may be sized for being slidably received within the lumen 26 of the tubular member 20 , although the advancer member 30 may abut or otherwise interact with the hub 23 of the cartridge 16 , e.g., such that the advancer member 30 is advanced distally when the cartridge 16 is advanced.
- the distal end 34 of the advancer member 30 may terminate in a substantially blunt distal tip, e.g., to facilitate contacting, pushing, and/or maintaining the sealant 2 within a puncture, as described further below.
- the advancer member 30 may be substantially rigid, semi-rigid, and/or substantially flexible, having sufficient column strength to allow proximal movement of the tubular member 20 relative to the sealant 2 without buckling the advancer member 30 and/or to allow the distal end 34 of the advancer member 30 to be advanced to compress the sealant 2 within a puncture, e.g., by pushing from the proximal end 32 , as described further below.
- the advancer member 30 may also include a lumen 36 extending between the proximal and distal ends 32 , 34 , e.g., to accommodate the positioning member 14 , a guidewire, a flowable sealing compound, and/or fluid (not shown).
- the advancer member 30 may include one or more elements (not shown) on the proximal end 32 , e.g., for interacting with one or more cooperating elements (also not shown) on the positioning member 14 , e.g., to limit movement of the advancer member 30 relative to the positioning member 14 .
- the element(s) may simply be a relatively narrow region (not shown) on the proximal end 32 .
- the element(s) may be a separate collar or sleeve, one or more inwardly oriented detents, and the like (also not shown) attached to or otherwise formed on the proximal end 32 of the advancer member 30 .
- the sealant 2 may be disposed within the lumen 26 of the tubular member 20 proximate to the distal end 24 , e.g., immediately adjacent the distal tip 25 , as shown in FIG. 2A .
- the lumen 26 may be sized such that the tubular member 20 and sealant 2 are slidable relative to one another, e.g., to allow the tubular member 20 to be retracted proximally relative to the sealant 2 and/or advancer member 30 , as described further below.
- the sealant 2 may include a biocompatible, bioabsorbable, and/or expandable material, such as a freeze-dried hydrogel.
- the sealant 2 may have a solid or hollow cylindrical shape, a rolled sheet shape, a disk shape, or other shapes or cross-sections, such as elliptical, triangular, square, conical, disk, polygonic shapes.
- the sealant 2 may be formed from a solid material including a lumen (not shown) extending between proximal and distal ends thereof.
- the lumen may be created by rolling a sheet of material around a mandrel, by molding, by boring into or otherwise removing material from an already formed solid material, and the like.
- the lumen may be dimensioned such that the positioning member 14 , a guidewire or other instrument (not shown) may slide or otherwise pass through the sealant 2 , as described elsewhere herein.
- the sealant 2 may be formed from a biocompatible and/or bioabsorbable hydrogel, e.g., polyethylene glycol (“PEG”), or other synthetic material.
- the hydrogel may include a lyophilized (i.e., freeze-dried) PEG polymer that includes hydrolytically degradable chemical groups, e.g., including a macroporous polymer network, which may uptake fluid and expand when exposed to an aqueous environment.
- the magnitude of expansion or swelling may be significant, e.g., between about two and ten times (2 ⁇ -10 ⁇ ) its lyophilized size based on volume.
- the sealant 2 may include pro-thrombotic material, e.g., including one or more biological pro-thrombotics, such as collagen, fibrin, carboxymethylcellulose, oxidized cellulose, alginates, gelatin, or other protein-based material, and/or synthetic materials, such as polyglycolic acids (PGA's), polyactides (PLA's), polyvinyl alcohol, and the like.
- pro-thrombotic material e.g., including one or more biological pro-thrombotics, such as collagen, fibrin, carboxymethylcellulose, oxidized cellulose, alginates, gelatin, or other protein-based material, and/or synthetic materials, such as polyglycolic acids (PGA's), polyactides (PLA's), polyvinyl alcohol, and the like.
- the sealant 2 may include one or more therapeutic and/or pharmaceutical agents, e.g., to promote healing, prevent infection and/or other adverse medical events, and the like. Such agents may be embedded in the sealant material and/or applied as one or more coatings or layers.
- the sealant 2 may be substantially homogeneous, or may include one or more different materials at one or more locations.
- the sealant 2 may include a carrier or core having first and second hydrogel precursors disposed thereon in an unreactive state, which may provide an adherent coating when the sealant 2 is exposed to an aqueous environment.
- the cartridge 16 includes a sleeve or cover 50 slidably disposed over the tubular member 20 , e.g., for covering the distal end 24 before use and/or advancement of the cartridge 16 .
- the sleeve 50 may support the distal end 24 , e.g., by covering the distal tip 25 and preventing premature expansion or separation of the slits 27 , e.g., before the distal end 24 is exposed from the sleeve 50 , as described further below.
- the sleeve 50 may include a relatively large diameter proximal portion 52 , e.g., sized to abut or otherwise contact a hub or proximal end of an introducer sheath (not shown), and a relatively small diameter distal portion 54 , e.g., sized to enter the hub and/or lumen of the introducer sheath (not shown).
- the introducer sheath hub may include one or more valves, e.g., a hemostatic valve therein, and the sleeve distal portion 54 may be sized to enter the hub and at least partially open the valve when the cartridge 16 is advanced, e.g., to facilitate the distal end 24 of the tubular member 20 entering the introducer sheath lumen, as described further below.
- valves e.g., a hemostatic valve therein
- the sleeve distal portion 54 may be sized to enter the hub and at least partially open the valve when the cartridge 16 is advanced, e.g., to facilitate the distal end 24 of the tubular member 20 entering the introducer sheath lumen, as described further below.
- the sleeve 50 may have a relatively short length compared to the tubular member 20 , e.g., such that the sleeve 50 may slide proximally over the tubular member 20 a desired distance.
- the sleeve 50 may have an overall length between about twelve and twenty four millimeters (12-24 mm), and the distal portion 54 may have a length, e.g., between about three and twenty millimeters (3-20 mm).
- the sleeve 50 may include an inner lumen 56 configured to provide preferential and/or different frictional interference with an outer surface of the tubular member 20 .
- the inner lumen 56 may allow the sleeve 50 to slide freely proximally relative to the tubular member 20 , while providing enhanced friction that resists distal movement of the sleeve 50 over the tubular member 20 .
- the sleeve 50 may be releasably attached to the cartridge 16 , e.g., using a low bond adhesive, and the like, which may be released or otherwise overcome when the cartridge 16 is advanced into an introducer sheath, as described further below.
- the sleeve 50 may be formed from an outer annular body 53 defining the proximal portion 52 , and a section of tubing 55 at least partially received within the annular portion 53 , e.g., defining the distal portion 54 .
- the components of the sleeve 50 may be made from the same or different materials, e.g., plastic, metal, or composite materials.
- the tubing 55 may be formed from substantially rigid plastic, such as polyimide
- the annular body 53 may be formed from polyether block amide (PEBAX), polyurethane, silicone, or other relatively soft durometer materials.
- the components may be attached to one another, e.g., by bonding with adhesive, ultrasonic welding, fusing, melting, and the like.
- annular portion 53 a of the annular body 53 and the tubing 55 together define the lumen 56 that extends through the sleeve 50 .
- the lumen 56 may be sized to allow the sleeve 50 to slide over the tubular member 20 (not shown, see, e.g., FIGS. 1A-2A ), e.g., while providing a slight interference.
- the annular portion 53 a adjacent the tubing 55 may have an inner diameter slightly smaller than the inner diameter 55 a of the tubing 55 , such that, when the sleeve 50 is directed proximally over the tubular member 20 (e.g., when the tubular member 20 is advanced distally relative to the sleeve 50 ), the soft durometer material of the annular portion 53 a may bunch up slightly, thereby expanding the size of the lumen 56 and reducing frictional interference between the sleeve 50 and the tubular member 20 .
- the annular portion 53 a surrounding the lumen 56 may stretch slightly, thereby reducing the size of the lumen 56 within the annular portion 53 a and increasing frictional interference between the annular portion 53 a of the sleeve 50 and the tubular member 20 . In this manner, the sleeve 50 may slide freely proximally while being substantially prevented from sliding distally over the tubular member 20 .
- the positioning member 14 generally includes an elongate member 40 including a proximal end 42 (not shown, see, e.g., FIG. 3B ), a distal end 44 , and an occlusion or positioning element 46 on the distal end 44 .
- the positioning element 46 may be an expandable member, such as a balloon, a wire mesh structure, an expandable frame, and the like.
- the positioning element 46 may be selectively expandable, e.g., using a source of inflation media, a pull wire, and/or other actuator (not shown), operable from the proximal end 42 of the positioning member 14 .
- the positioning element may be a balloon 46
- the positioning member 14 may include a tubular body 40 including a lumen (not shown) extending between the proximal and distal ends 42 , 44 and communicating with an interior of the balloon 46 .
- the positioning member 14 may include a source of inflation media, e.g., a syringe (not shown), that may be coupled to a housing 48 on the proximal end 142 of the positioning member 14 .
- the positioning member 14 may include an internal pull wire (not shown) that causes the balloon 46 to shorten during expansion and extend during collapse.
- Exemplary embodiments of positioning members 14 including balloons that may be used are disclosed in co-pending application Ser. Nos.
- the positioning element may be biased to an enlarged condition, but may be compressed to a contracted condition, e.g., by an overlying sleeve or other constraint (not shown).
- the constraint may be removed to expose the positioning element, allowing the expandable element to automatically expand to the enlarged condition. Additional information on expandable structures that may be provided on the positioning member 14 may be found in U.S. Pat. Nos. 6,238,412, 6,635,068, and 6,890.343, and in co-pending application Ser. No. 10/975,205, filed Oct. 27, 2004. The entire disclosures of these references are expressly incorporated herein by reference.
- the apparatus 10 may be used to position and deliver the sealant 2 within a puncture, e.g., extra-vascularly just above or otherwise adjacent to an arteriotomy in a blood vessel or other body lumen communicating with a puncture, as described further elsewhere herein.
- a puncture e.g., extra-vascularly just above or otherwise adjacent to an arteriotomy in a blood vessel or other body lumen communicating with a puncture, as described further elsewhere herein.
- the cartridge 16 (along with the advancer member 30 and sealant 2 within the tubular member 20 ) may be initially provided on the proximal end 42 of the positioning member 14 .
- the housing 48 on the positioning member 14 and the hub 23 on the cartridge 16 may be initially connected to one another, e.g., using one or more releasable detents 23 a , 48 a , as shown in FIG. 4A .
- the cartridge 16 may be slidable distally along the positioning member 14 , e.g., by disconnecting the hub 23 from the housing 48 , and then advancing the cartridge 16 , e.g., until the distal end 24 of the tubular member 20 is disposed adjacent the positioning element 46 .
- the detents 23 a , 48 a may simply separate from one another when the hub 23 is advanced away from the housing 48 with sufficient force.
- one of the hub 23 and housing 48 may include an actuator or lock that may be activated (not shown) to separate the detents 23 a , 48 a and/or otherwise allow the cartridge 16 to be advanced relative to the positioning member 14 .
- the cartridge 16 and/or positioning member 14 may include cooperating features that limit distal movement of the cartridge 16 relative to the positioning member 14 .
- the hub 23 of the cartridge 16 may include a pocket 23 b and the positioning member 14 may include a detent or other feature 41 a that may be received within the pocket 23 b when the cartridge 16 is advanced to a distal position.
- the handle 23 of the cartridge 16 may include a window or other opening (not shown) through which the pocket 23 b may be seen, e.g., to allow a user to visually confirm when the detent 41 has been fully received in the pocket 23 b.
- the detent 41 a may be provided on the outer surface of the elongate member 40 at a predetermined location between the proximal and distal ends 42 , 44 such that the distal end 24 of the tubular member 20 is spaced apart from the positioning element 46 by a predetermined distance, e.g., providing between about two and five millimeters (2-5 mm) clearance between the distal end 24 and the positioning element 46 .
- the detent 41 a may be provided at a predetermined location such that the distal end 24 of the tubular member may be jammed or otherwise extend into the positioning element 46 , e.g., by zero to two millimeters (0-2 mm).
- the detent 41 a may be a raised feature formed or attached to the elongate member 40 at the predetermined location.
- the detent may be a proximal end of a section of tubing, e.g., heat shrink tubing, a collar, or other sleeve (not shown) attached around the elongate member 40 , e.g., by bonding with adhesive, heat shrinking, ultrasonic welding, fusing, crimping, and the like.
- the detent 41 a may overmolded or otherwise formed directly on the elongate member 40 , as desired.
- the positioning member 14 and/or advancer member 30 may include one or more elements that engage when the cartridge 16 reaches a predetermined location when advanced along the positioning member 14 , e.g., to limit subsequent proximal movement of the advancer member 30 relative to the positioning member 14 when the tubular member 20 is subsequently retracted.
- the positioning member 14 may include a reduced diameter region (not shown) at a predetermined location, e.g., by providing a larger tube around a smaller inner tube or by machining, etching, or otherwise removing a portion of the tubular body of the positioning member 14 distal to the reduced region.
- the larger tube may extend from the proximal end of the positioning member 14 to the desired location for the detent, or may simply be a relatively short sleeve or other member (not shown) attached around or to the positioning member 14 at the desired location, e.g., to provide a first ratchet or detent that the advancer member 30 may pass over freely in the distal direction but not subsequently move proximally.
- the advancer member 30 may include a living hinge, tab, or other element 37 (also not shown) on the proximal end 32 that may pass freely over the reduced regions, ratchets, and/or other detents on the positioning member 14 , yet may be unable to pass proximally back over the reduced region.
- the positioning member 14 may include a ring, tab, or other raised element, e.g., a first and a second raised element or other detent 41 a , 41 b
- the advancer member 30 may include a corresponding element (also not shown) that may allow distal advancement but prevent proximal retraction once the advancer member 30 is advanced a predetermined distance.
- the first detent 41 a may be provided at a predetermined location on the positioning member 14 , e.g., a predetermined distance from the positioning element 46 that substantially corresponds to a length of the advancer member 30 . As the cartridge 16 (and consequently the advancer member 30 ) is advanced over the positioning member 14 , e.g., until the sealant 2 is disposed adjacent the positioning element 46 , the element 37 on the advancer member 30 may pass freely over the first detent 41 a , as best seen in FIG. 4B .
- the element 37 may prevent the advancer member 30 from being retracted again past the first detent 41 a , e.g., due to a blunt edge of the element 37 abutting the abrupt distal edge of the first detent 41 a .
- the element 37 may prevent the advancer member 30 from retracting with the tubular member 20 .
- a second ratchet or detent 41 b may be provided on the positioning member 14 distal to the first detent 41 a , e.g., over which the advancer member 30 may be advanced further, e.g., during compression of the sealant 2 after deployment, as described further below.
- the second detent 41 b may be another tube or other feature (not shown) attached to or formed on the positioning member 14 , e.g., that provides a blunt distal edge.
- one or more markers may be provided on the apparatus 10 , e.g., to identify when components are located at one or more desired positions or otherwise to facilitate use of the apparatus 10 .
- the positioning member 14 may include one or more markers at predetermined locations on the elongate member 40 . Such markers may provide visual confirmation when the cartridge 16 has been advanced to a desired distal position, e.g., when the marker(s) 43 emerge from the hub 23 as the cartridge 16 is advanced over the positioning member 14 .
- the advancer member 30 may include one or more markers 33 thereon, which may be visible when the cartridge 16 is advanced to a distal position and the tubular member 20 is retracted to expose the sealant 2 .
- markers 33 may also provide visual guides to inform the user when the advancer member 30 is manipulated, e.g., advanced into a puncture to compress the sealant 2 therein, as described further below.
- the apparatus 10 is generally used in cooperation with an introducer sheath 80 .
- the introducer sheath 80 may part of a system or kit including the apparatus 10 or may be an independent device.
- the introducer sheath 80 includes a proximal end 82 , a distal end 84 sized for insertion into a puncture 90 through tissue, and a lumen 86 extending between the proximal and distal ends 82 , 84 .
- the introducer sheath 80 may be formed from a substantially rigid, semi-rigid, and/or flexible tubular body including a hub 83 on the proximal end 82 .
- the introducer sheath 80 may have sufficient length to extend from a patient's skin through any intervening tissue into a blood vessel or other body lumen, e.g., having a length between about ten centimeters and twenty centimeters (10-20 cm), and may have an outer diameter between about 1.6 millimeters and five millimeters (1.6-5 mm).
- the distal end 84 may be tapered and/or may include a substantially atraumatic distal tip 85 for facilitating advancement through a puncture.
- the introducer sheath 80 may be formed using known materials and/or methods, e.g., plastic with the tubular body and hub 83 substantially permanently connected together, e.g., using an interference fit, one or more mating connectors (not shown), bonding with adhesive, ultrasonic welding, and the like.
- the hub 83 generally includes one or more seals, e.g., one or more hemostatic seals (not shown) therein, which may prevent flow of blood or other fluids out of the hub 83 from the lumen 86 , yet accommodate insertion of one or more instruments into the lumen 26 , such as the positioning member 14 and/or cartridge 16 .
- the hub 83 may include a side port 89 communicating with the lumen 86 , e.g., for coupling a source of saline or other fluid (not shown) to the hub 83 .
- FIGS. 5A-5D an exemplary method is shown for sealing a puncture 90 , e.g., using the apparatus 10 to deliver a sealant 2 , e.g., to achieve hemostasis within the puncture 90 .
- the puncture 90 extends from a patient's skin 92 through intervening tissue 96 , e.g., to a body lumen 94 .
- the puncture 90 may be a percutaneous puncture communicating with a blood vessel 94 , such as a femoral artery, carotid artery, and the like.
- the puncture 90 may be created using known procedures, e.g., using a needle, guidewire, one or more dilators, and the like (not shown).
- An introducer sheath 80 may be advanced through the puncture 90 into the vessel 94 , e.g., over a guide wire placed through the puncture 90 into the vessel 94 .
- the introducer sheath 80 may provide access into the vessel 92 for one or more instruments (not shown), e.g., to allow one or more diagnostic and/or interventional procedures to be performed via the vessel 94 .
- any such instrument(s) may be removed from the puncture 90 , leaving the introducer sheath 80 extending through the puncture 90 into the vessel 94 .
- the positioning member 14 may be introduced into and/or through the lumen 46 of the introducer sheath 80 , e.g., with the expandable positioning element 46 in a collapsed condition.
- the cartridge 16 along with the sealant 2 and advancer member 30 , may be provided initially on the proximal end 42 of the positioning member 40 , e.g., as shown in FIG. 3A .
- the distal end 24 of the tubular member 20 may initially be located outside the puncture 90 when the positioning member 40 is advanced into the puncture 90 .
- the distal end 44 of the positioning member 140 may be inserted through the puncture 90 (via the introducer sheath 80 ) and into the vessel 94 .
- the positioning element 46 Once the positioning element 46 is disposed within the vessel 94 , i.e., beyond the distal end 84 of the introducer sheath 80 , the positioning element 46 may be expanded to an enlarged condition, as shown.
- the positioning member 40 After expanding the positioning element 46 , the positioning member 40 may be at least partially withdrawn until the positioning element 46 contacts the wall of the vessel 94 , e.g., to substantially seal the vessel 94 from the puncture 90 .
- this may involve a two-step process (although it may be completed in a single substantially continuous action).
- the positioning member 14 may be withdrawn until the positioning element 46 contacts the distal end 84 of the introducer sheath 80 , which may provide a first tactile feedback to the user (i.e., that the positioning element 46 has contacted the introducer sheath 80 , e.g., based upon the increased weight and/or resistance to proximal movement).
- the positioning member 14 may be withdrawn further until the positioning element 46 contacts the wall of the vessel 94 and resists further withdrawal, thereby providing a second tactile feedback.
- the introducer sheath 80 may be pulled proximally by the positioning element 46 as the positioning member 14 is withdrawn, e.g., until the distal end 84 of the introducer sheath 80 is withdrawn from the vessel 94 into the puncture 90 , as shown in FIG. 5A .
- Proximal tension may be applied and/or maintained on the positioning member 14 to hold the positioning element 46 against the wall of the vessel 94 , e.g., to seal the puncture 90 from the vessel 94 and/or prevent further removal of the positioning member 14 .
- the proximal tension may be maintained manually or using a tensioner device (not shown) to provide temporary hemostasis, e.g., during the subsequent steps.
- Exemplary tension devices are disclosed in co-pending application Ser. No. 10/806,952, filed Mar. 22, 2004, the entire disclosure of which is expressly incorporated herein by reference.
- the cartridge 16 (carrying the sealant 2 ) may be advanced distally over the positioning member 14 into the puncture 90 .
- FIGS. 3A and 3B show the cartridge 16 , carrying the sleeve 50 over the distal end 24 of the tubular member 20 , being advanced distally over the positioning member 14 towards the introducer sheath 80 .
- the sleeve 50 may contact the introducer sheath 80 , which may prevent further advancement of the sleeve 50 .
- the distal portion 54 of the sleeve 50 may at least partially enter the hub 83 of the introducer sheath 80 and the proximal portion 52 of the sleeve 50 may abut the hub 83 , as shown in FIGS. 5B and 5C , thereby preventing further advancement of the sleeve 50 . If the sleeve 50 is releasably attached to the tubular member 20 , advancement of the cartridge 16 to this point may release the sleeve 50 from the tubular member 20 .
- the cartridge 16 may be further advanced into the introducer sheath 80 toward the positioning element 46 , whereupon the sleeve 50 may remain substantially stationary relative to the introducer sheath 80 and, consequently, slide proximally over the tubular member 20 .
- the distal end 24 of the tubular member 20 may exit the distal portion 54 of the sleeve 50 and enter the introducer sheath lumen 86 .
- the distal portion 54 of the sleeve 50 may have sufficient length to at least partially open the valve(s) within the introducer sheath hub 83 , e.g., to facilitate the distal end 24 of the tubular member 20 being advanced into the introducer sheath lumen 86 .
- the sleeve 50 may protect the slitted distal tip 25 of the tubular member 20 until the distal tip 25 passes into the hub 83 and/or lumen 86 of the introducer sheath 80 .
- the cartridge 16 may be advanced until a component of the cartridge 16 encounters a stop on the positioning member 14 , thereby preventing further advancement of the cartridge 16 and/or spacing the sealant 2 a predetermined distance from the positioning element 46 , e.g., about zero to five millimeters (0-5 mm) from the positioning element 46 or zero to two millimeters (0-2 mm) into or beyond the positioning member 14 .
- the cartridge 16 may be advanced until the detent 41 a on the positioning member 14 enters the recess 23 b in the cartridge hub 23 .
- the cartridge 16 may be advanced into the introducer sheath 80 until the distal end 24 contacts the expanded positioning element 46 (not shown), which may provide tactile feedback that the cartridge 16 has been advanced sufficiently, or the sealant 2 is otherwise positioned within the puncture 90 .
- the tubular member 20 of the cartridge 16 may be retracted, e.g., by pulling proximally on the hub 83 of the introducer sheath 80 , to withdrawn the introducer sheath 80 and tubular member 20 from the puncture 90 and expose the sealant 2 within the puncture beyond the introducer sheath distal end 84 .
- the sleeve 50 may include one or more locking elements (not shown) that may couple the introducer sheath 80 to the sleeve 50 , similar to the embodiments disclosed in application Ser. No. 11/864,835, filed Sep. 28, 2007, and published as U.S. Publication No.
- the advancer member 30 may prevent substantial proximal movement of the sealant 2 , thereby exposing the sealant 2 within the puncture 90 , as shown in FIG. 5D .
- the feature(s) 37 on the proximal end 32 of the advancer member 30 may pass over the reduced region or first detent 41 a of the positioning member 14 , as shown in FIG. 4B , thereby preventing subsequent proximal withdrawal of the advancer member 30 relative to the positioning member 14 .
- the element 37 on the advancer member 30 may abut the blunt distal edge of the reduced region or first detent 41 a , thereby preventing substantial proximal movement of the advancer member 30 , and the sealant 2 adjacent the distal end 34 of the advancer member 30 .
- the sealant 2 When the sealant 2 is exposed within the puncture 90 , the sealant 2 may be exposed to blood and/or other body fluids within the puncture 90 . This exposure may cause the sealant 2 to absorb fluid and/or otherwise expand within the puncture 90 , e.g., to provide hemostasis.
- the advancer member 30 may be advanced to compress or tamp the sealant 2 , e.g., against the positioning element 46 .
- the advancer member 30 may include one or more markers 33 , e.g., on or adjacent the proximal end 32 , and the advancer member 30 may be advanced into the puncture 90 a desired distance, which may be confirmed by monitoring the markers 33 .
- the positioning member 14 may include a second detent 41 b over which the advancer member 30 may pass when advanced a predetermined distance.
- the second detent 41 b may provide an audible confirmation that the advancer member 30 has been advanced the predetermined distance (in addition or instead of the visible confirmation provided by the markers 33 ).
- the second detent 41 b may ensure that the advancer member 30 is not subsequently withdrawn once advanced the predetermined distance.
- the positioning element 46 may be collapsed, and the positioning member 14 withdrawn from the vessel 94 and puncture 90 , e.g., pulling the collapsed positioning element 46 through the sealant 2 and advancer member 30 .
- the advancer member 30 may be maintained substantially stationary during withdrawal of the positioning member 14 , e.g., to prevent migration and/or dislodgment of the sealant 2 within the puncture 90 .
- the advancer member 30 may be removed from the puncture 90 , leaving the sealant 2 within the puncture 90 .
- liquid hydrogel or other sealing compound, or other material may be delivered into the puncture 90 , e.g., above and/or around the sealant 2 , to assist in achieving hemostasis.
- such material may be delivered via the lumen 36 of the advancer member 30 and/or by introducing another delivery device (not shown) into the puncture 90 , e.g., after removing the advancer member 30 .
Abstract
Description
- The present invention relates generally to apparatus and methods for sealing punctures in a body, and more particularly, to apparatus and methods for sealing a vascular puncture extending through tissue into a blood vessel, and to apparatus and methods for delivering a plug, sealant, and/or other material into a percutaneous puncture extending from a patient's skin to a blood vessel or other body lumen, e.g., to seal the puncture.
- Apparatus and methods are known for accessing a patient's vasculature percutaneously, e.g., to perform a procedure within the vasculature, and for sealing the puncture that results after completing the procedure. For example, a hollow needle may be inserted through a patient's skin and overlying tissue into a blood vessel. A guide wire may be passed through the needle lumen into the blood vessel, whereupon the needle may be removed. An introducer sheath may then be advanced over the guide wire into the vessel, e.g., in conjunction with or subsequent to one or more dilators.
- A catheter or other device may be advanced through the introducer sheath and over the guide wire into a position for performing a medical procedure. Thus, the introducer sheath may facilitate accessing and/or introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss. Upon completing the procedure, the device(s) and introducer sheath may be removed, leaving a puncture extending between the skin and the vessel wall.
- To seal the puncture, external pressure may be applied to the overlying tissue, e.g., manually and/or using sandbags, until hemostasis occurs. This procedure, however, may be time consuming and expensive, requiring as much as an hour of a medical professional's time. It is also uncomfortable for the patient, and may require the patient to remain immobilized in the operating room, catheter lab, or holding area. In addition, a risk of hematoma exists from bleeding before hemostasis occurs.
- Various apparatus and methods have been suggested for sealing a percutaneous puncture instead of using external pressure. For example, U.S. Pat. No. 5,108,421 to Fowler discloses a plug that may be delivered into a puncture through tissue. U.S. Pat. Nos. 5,192,302 and 5,222,974 issued to Kensey et al. describe a bioabsorbable collagen plug that may be delivered through an introducer sheath into a puncture site. The disclosed plug, however, may be difficult to position properly with respect to the vessel, which may be significant since it is generally undesirable to expose the collagen material within the bloodstream where it may float downstream and cause an embolism.
- U.S. Pat. No. 6,605,294 describes rods, plugs, and crushed or irregularly shaped pieces of substantially dehydrated hydrogel that may be introduced into a lumen or void in a patient's body, e.g., to seal or plug a biopsy needle track, reinforce weak tissue, or deliver a therapeutic compound. In one embodiment, a plug of dehydrated hydrogel may be deployed into the site of an arteriotomy and allowed to hydrate in the presence of the tissue fluids and blood, to fill the tract of the catheter sheath and prevent further bleeding. By swelling to equilibrium hydration, the plug may lock itself firmly in place and thus reduce the risk of formation of a large hematoma at the site of the puncture.
- U.S. Pat. No. 6,703,047 discloses dehydrated hydrogel precursor-based, tissue adherent compositions. The hydrogels may be used, for example, for sealing fluid leaks from tissue, as adherent drug delivery depots, and as means for augmenting and/or supporting tissue. The hydrogels may be administered directly to an open wound site or may be dispensed, e.g., using a non-adhesive backing material, an absorbable backing material, a syringe applicator, a powder atomization or aerosolization system, or a needle-less injector.
- The present invention is directed to apparatus and methods for sealing a puncture in a body, and, more particularly, to apparatus and methods for providing temporary or permanent hemostasis within a vascular puncture extending into a blood vessel, and/or to apparatus and methods for delivering a sealant and/or other material into a percutaneous puncture extending from a patient's skin to a blood vessel or other body lumen.
- In accordance with one embodiment, an apparatus is provided for sealing a puncture extending through tissue having an introducer sheath therein that includes a proximal end including a hub, a distal end, and a lumen extending therebetween. The apparatus includes an elongate positioning member including a housing on a proximal end thereof, and an expandable positioning element on a distal end thereof, and a cartridge advanceable along the positioning member from a proximal position adjacent the housing to a distal position. The cartridge may include a tubular member, a sealant disposed within a lumen of the tubular member, e.g., adjacent the tubular member distal end, and an advancer member disposed within the tubular member lumen adjacent the sealant, e.g., for exposing the sealant from the tubular member lumen when the tubular member is retracted proximally relative to the advancer member.
- In addition, the cartridge includes a sleeve slidably disposed over the tubular member distal end, e.g., covering a slitted distal tip of the tubular member. Optionally, the sleeve may include an inner surface configured to provide preferential or different frictional interference with an outer surface of the tubular member, e.g., to allow proximal movement and resist distal movement of the sleeve over the tubular member. At least a portion of the sleeve may be sized to abut the introducer sheath hub such that, when the tubular member is advanced from the proximal position to the distal position, the tubular member distal end enters the introducer sheath lumen while the sleeve is stopped by the introducer sheath hub and slides over the tubular member to expose the tubular member distal end within the introducer sheath lumen.
- For example, in one embodiment, the sleeve may include a distal portion sized to enter the introducer sheath hub when the cartridge is advanced towards the distal position and a proximal portion that abuts the introducer sheath hub to prevent the entire sleeve from entering the introducer sheath lumen. The introducer sheath hub may include a valve therein, and the sleeve distal portion may at least partially open the valve when the cartridge is advanced towards the distal position, e.g., to facilitate the tubular member distal end entering the introducer sheath lumen.
- Optionally, the positioning member and/or cartridge may include one or more features that limit distal movement of the tubular member when the cartridge is advanced from the proximal position to the distal position. For example, features may be provided on the positioning member to prevent further distal movement of the tubular member when the tubular member distal end is spaced a predetermined distance from the positioning element.
- In accordance with another embodiment, a system is provided for sealing a puncture through tissue that generally includes an introducer sheath, a positioning member, and a cartridge. The introducer sheath may include a proximal end including a hub, a distal end sized for introduction into a puncture, and a lumen extending therebetween. The positioning member may include an elongate member including a housing on a proximal end thereof and an expandable positioning element on a distal end thereof. The cartridge may be advanceable along the positioning member from a proximal position to a distal position, and may include a tubular member including a sealant and an advancer member disposed within lumen of the tubular member. A sleeve is slidably disposed over the tubular member distal end such that, when the tubular member is advanced over the positioning member after introducing the positioning element through the introducer sheath, the tubular member distal end enters the introducer sheath lumen while the sleeve is stopped by the introducer sheath hub and slides over the tubular member to expose the tubular member distal end within the introducer sheath lumen.
- In accordance with still another embodiment, a method is provided for sealing a puncture extending through tissue to a body lumen, the puncture having an introducer sheath therein. An apparatus may be provided including an elongate positioning member including proximal and distal ends, a cartridge slidable on the positioning member and carrying a sealant therein, and a slidable sleeve located over a distal end of the cartridge.
- The distal end of the positioning member may be introduced through a lumen of the introducer sheath until a positioning element thereon is disposed within the body lumen. Optionally, the positioning element may be expanded within the body lumen, and the positioning member may be refracted until the expanded positioning element contacts a wall of the body lumen.
- The cartridge may be advanced over the positioning member, e.g., until the sleeve on the cartridge contacts a proximal end of the introducer sheath. The cartridge may be advanced further, e.g., as one substantially continuous movement, such that the cartridge distal end enters the introducer sheath lumen while the sleeve is stopped by the introducer sheath. During this further advancement, the sleeve may slide over the cartridge to expose the cartridge distal end within the introducer sheath lumen, e.g., until a distal position is attained.
- The introducer sheath and cartridge may then be at least partially retracted from the puncture, thereby exposing the sealant within the puncture distally beyond the introducer sheath. The expanded positioning element may then be collapsed, and the positioning member withdrawn from the puncture, e.g., leaving the sealant within the puncture. In one embodiment, the cartridge may include an advancer member adjacent the sealant that remains within the puncture when the introducer sheath and cartridge are retracted. In this embodiment, the positioning member may be withdrawn through the sealant and advancer member. For example, the advancer member may be held substantially stationary while the positioning member is withdrawn from the puncture to prevent substantial proximal movement of the sealant. In addition or alternatively, the advancer member may be advanced to compress the sealant within the puncture, e.g., before or after withdrawing the positioning member. The advancer member may then be withdrawn, leaving the sealant within the puncture.
- Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
- It will be appreciated that the exemplary apparatus shown in the drawings are not necessarily drawn to scale, with emphasis instead being placed on illustrating the various aspects and features of the illustrated embodiments.
-
FIGS. 1A and 1B are side and perspective views, respectively, of an exemplary embodiment of an apparatus for delivering a sealant into a puncture through tissue, including a positioning member, and a cartridge movable over the positioning member that includes the sealant and a slidable sleeve. -
FIG. 2A is a partial cross-section of the apparatus ofFIGS. 1A and 1B before the slidable sleeve is directed over a distal end of the cartridge. -
FIG. 2B is a cross-sectional detail of the sleeve ofFIG. 2A . -
FIGS. 3A and 3B are side views of the apparatus ofFIGS. 1A and 1B with the positioning member inserted into an introducer sheath, showing the cartridge in proximal and distal positions, proximally. -
FIGS. 4A and 4B are cross-sectional views of a housing on the cartridge of the apparatus ofFIGS. 3A and 3B , with the cartridge in proximal and distal positions, respectively. -
FIGS. 5A-5D are cross-sectional views of a patient's body, showing a method for sealing a puncture extending from a patient's skin to a blood vessel using the apparatus ofFIGS. 1A and 1B . - Turning to the drawings,
FIGS. 1A and 1B show an exemplary embodiment of anapparatus 10 for sealing a puncture through tissue. Generally, theapparatus 10 includes a positioningmember 14 and acartridge 16 carried on the positioningmember 14 for delivering asealant 2 therein into a puncture (not shown). As shown inFIGS. 3A and 3B , theapparatus 10 may be part of a system, e.g., which may also include a delivery, access, procedure, introducer, orother sheath 80. Optionally, theapparatus 10 and/or system may include one or more other components, e.g., a needle, guidewire, and/or other instrument for creating a puncture (not shown), and/or a source of additional sealing compound (also not shown). - As best seen in
FIG. 2A , thecartridge 16 includes an elongatetubular member 20 carrying thesealant 2 therein, anadvancer member 30 adjacent thesealant 2, and a slidable sleeve or cover 50, as described further below. Generally, thetubular member 20 includes aproximal end 22, adistal end 24 sized for introduction into an introducer sheath and/or puncture (not shown), and alumen 26 extending between the proximal and distal ends 22, 24. Thetubular member 20 may be substantially rigid, semi-rigid, or flexible, e.g., such that thetubular member 20 may be advanced through an introducer sheath or otherwise into a puncture through tissue. A handle orhub 23 may be provided on theproximal end 22, e.g., for releasably coupling thecartridge 16 to the positioningmember 14, as best seen inFIGS. 4A and 4B and described further below. - As shown in
FIG. 2A , adistal tip 25 of thetubular member 20 may be split, e.g., including one or more slits orother features 27, e.g., to facilitate exposing thesealant 2 from thecartridge 16. For example, a splitdistal tip 25 may facilitate retraction of thetubular member 20 relative to thesealant 2, e.g., by providing extra flexibility at thedistal end 24 and/or allowing thedistal end 24 to expand or otherwise open slightly. This may allow thedistal end 24 to separate more easily from thesealant 2, e.g., as the sealant begins to expand upon being exposed to an aqueous environment, which may reduce the risk of thesealant 2 binding up within or otherwise resisting exposure from thelumen 26 of thetubular member 20. - In addition, the
slits 27 may accommodate slight expansion of thesealant 2 before being exposed from thetubular member 20. For example, a distal surface of thesealant 2 may be exposed to bodily fluids when thecartridge 16 is advanced into a puncture, which may hydrate and cause the distal end of thesealant 2 to expand slightly. Optionally, thedistal end 24 of thetubular member 20 may be exposed to water or other fluid before use of theapparatus 10, e.g., to partially hydrate the distal end of thesealant 2 and cause the distal end to expand slightly. Theslits 27 may allow thedistal end 24 of thetubular member 20 to open to accommodate such expansion. Otherwise, if thesealant 2 hydrates and/or otherwise expands within thetubular member 20, thesealant 2 may impose radially outward forces, which may hinder retracting thetubular member 20 to expose thesealant 2. - In the exemplary embodiment shown, a single
longitudinal slit 27 is cut or otherwise formed on one side of thedistal tip 25 that extends proximally from thedistal tip 25, e.g., about ten to twenty millimeters (10-20 mm). Alternatively, a pair of slits may be provided, e.g., on opposite sides of thedistal tip 25 or more than two slits may be provided, if desired (not shown). The length of the slit(s) may be less than, substantially equal to, or longer than the length of thesealant 2, e.g., to reduce the risk of jamming if thesealant 2 begins to expand within thedistal tip 25, as described elsewhere herein. - A slit that is longer than the
sealant 2 may provide hydraulic benefits, e.g., when thecartridge 16 is advanced to introduce thesealant 2 into a puncture. For example, during use, as thecartridge 16 is advanced into an introducer sheath (not shown), as described further below, fluid inside the introducer sheath may be displaced distally by thecartridge 16, which may increase pressure at thedistal end 24 of thetubular member 20 and/or introducer sheath. This increased hydraulic pressure at thedistal end 24 of thetubular member 20 may also transmit along the sides of thecartridge 16, e.g., if there is a gap between the inner diameter of the introducer sheath and the outer diameter of thetubular member 20. A longer slit 27 may allow some relief of this pressure, e.g., by blood or other fluid within the introducer sheath flowing in directly behind thesealant 2 within thelumen 26 of thetubular member 20 and/or otherwise within thecartridge 16. Such infusion behind thesealant 2 may also have the benefit of pre-hydrating thesealant 2, which may enhance the ability of thesealant 2 to expand quickly when deployed within a puncture or otherwise within the patient's body. - With further reference to
FIG. 2A , theadvancer member 30 may be an elongate tubular body, e.g., a plunger or catheter, including aproximal end 32, adistal end 34 sized for introduction into thelumen 26 of thetubular member 20, and alumen 36 extending between the proximal and distal ends 32, 34. Theadvancer member 30 may be sized for being slidably received within thelumen 26 of thetubular member 20, although theadvancer member 30 may abut or otherwise interact with thehub 23 of thecartridge 16, e.g., such that theadvancer member 30 is advanced distally when thecartridge 16 is advanced. Thedistal end 34 of theadvancer member 30 may terminate in a substantially blunt distal tip, e.g., to facilitate contacting, pushing, and/or maintaining thesealant 2 within a puncture, as described further below. - The
advancer member 30 may be substantially rigid, semi-rigid, and/or substantially flexible, having sufficient column strength to allow proximal movement of thetubular member 20 relative to thesealant 2 without buckling theadvancer member 30 and/or to allow thedistal end 34 of theadvancer member 30 to be advanced to compress thesealant 2 within a puncture, e.g., by pushing from theproximal end 32, as described further below. Theadvancer member 30 may also include alumen 36 extending between the proximal and distal ends 32, 34, e.g., to accommodate the positioningmember 14, a guidewire, a flowable sealing compound, and/or fluid (not shown). - Optionally, the
advancer member 30 may include one or more elements (not shown) on theproximal end 32, e.g., for interacting with one or more cooperating elements (also not shown) on the positioningmember 14, e.g., to limit movement of theadvancer member 30 relative to the positioningmember 14. For example, the element(s) may simply be a relatively narrow region (not shown) on theproximal end 32. Alternatively, the element(s) may be a separate collar or sleeve, one or more inwardly oriented detents, and the like (also not shown) attached to or otherwise formed on theproximal end 32 of theadvancer member 30. - The
sealant 2 may be disposed within thelumen 26 of thetubular member 20 proximate to thedistal end 24, e.g., immediately adjacent thedistal tip 25, as shown inFIG. 2A . Thelumen 26 may be sized such that thetubular member 20 andsealant 2 are slidable relative to one another, e.g., to allow thetubular member 20 to be retracted proximally relative to thesealant 2 and/oradvancer member 30, as described further below. - The
sealant 2 may include a biocompatible, bioabsorbable, and/or expandable material, such as a freeze-dried hydrogel. Thesealant 2 may have a solid or hollow cylindrical shape, a rolled sheet shape, a disk shape, or other shapes or cross-sections, such as elliptical, triangular, square, conical, disk, polygonic shapes. For example, thesealant 2 may be formed from a solid material including a lumen (not shown) extending between proximal and distal ends thereof. The lumen may be created by rolling a sheet of material around a mandrel, by molding, by boring into or otherwise removing material from an already formed solid material, and the like. The lumen may be dimensioned such that the positioningmember 14, a guidewire or other instrument (not shown) may slide or otherwise pass through thesealant 2, as described elsewhere herein. - In one embodiment, the
sealant 2 may be formed from a biocompatible and/or bioabsorbable hydrogel, e.g., polyethylene glycol (“PEG”), or other synthetic material. For example, the hydrogel may include a lyophilized (i.e., freeze-dried) PEG polymer that includes hydrolytically degradable chemical groups, e.g., including a macroporous polymer network, which may uptake fluid and expand when exposed to an aqueous environment. The magnitude of expansion or swelling (pre to post hydration) may be significant, e.g., between about two and ten times (2×-10×) its lyophilized size based on volume. - In addition or alternatively, the
sealant 2 may include pro-thrombotic material, e.g., including one or more biological pro-thrombotics, such as collagen, fibrin, carboxymethylcellulose, oxidized cellulose, alginates, gelatin, or other protein-based material, and/or synthetic materials, such as polyglycolic acids (PGA's), polyactides (PLA's), polyvinyl alcohol, and the like. - Optionally, the
sealant 2 may include one or more therapeutic and/or pharmaceutical agents, e.g., to promote healing, prevent infection and/or other adverse medical events, and the like. Such agents may be embedded in the sealant material and/or applied as one or more coatings or layers. In addition or alternatively, thesealant 2 may be substantially homogeneous, or may include one or more different materials at one or more locations. For example, in one embodiment, thesealant 2 may include a carrier or core having first and second hydrogel precursors disposed thereon in an unreactive state, which may provide an adherent coating when thesealant 2 is exposed to an aqueous environment. - Exemplary materials and methods for making and using them are disclosed in U.S. Pat. Nos. 6,152,943, 6,165,201, 6,179,862, 6,514,534, 6,379,373, 6,703,047, 7,790,192, and in co-pending application Ser. Nos. 10/010,715 filed Nov. 9, 2001, 10/068,807 filed Feb. 5, 2002, 10/454,362, filed Jun. 4, 2003, published as US 2004/0249342, 10/982,384, filed Nov. 5, 2004, published as US 2006/0099238, and 11/465,791, filed Aug. 18, 2006. The disclosures of these references are expressly incorporated by reference herein.
- Additionally, as shown in
FIGS. 1A and 1B , thecartridge 16 includes a sleeve or cover 50 slidably disposed over thetubular member 20, e.g., for covering thedistal end 24 before use and/or advancement of thecartridge 16. For example, thesleeve 50 may support thedistal end 24, e.g., by covering thedistal tip 25 and preventing premature expansion or separation of theslits 27, e.g., before thedistal end 24 is exposed from thesleeve 50, as described further below. - As best seen in
FIGS. 2A and 2B , thesleeve 50 may include a relatively large diameterproximal portion 52, e.g., sized to abut or otherwise contact a hub or proximal end of an introducer sheath (not shown), and a relatively small diameterdistal portion 54, e.g., sized to enter the hub and/or lumen of the introducer sheath (not shown). For example, the introducer sheath hub may include one or more valves, e.g., a hemostatic valve therein, and the sleevedistal portion 54 may be sized to enter the hub and at least partially open the valve when thecartridge 16 is advanced, e.g., to facilitate thedistal end 24 of thetubular member 20 entering the introducer sheath lumen, as described further below. - The
sleeve 50 may have a relatively short length compared to thetubular member 20, e.g., such that thesleeve 50 may slide proximally over the tubular member 20 a desired distance. For example, thesleeve 50 may have an overall length between about twelve and twenty four millimeters (12-24 mm), and thedistal portion 54 may have a length, e.g., between about three and twenty millimeters (3-20 mm). - Optionally, the
sleeve 50 may include aninner lumen 56 configured to provide preferential and/or different frictional interference with an outer surface of thetubular member 20. For example, theinner lumen 56 may allow thesleeve 50 to slide freely proximally relative to thetubular member 20, while providing enhanced friction that resists distal movement of thesleeve 50 over thetubular member 20. In addition or alternatively, thesleeve 50 may be releasably attached to thecartridge 16, e.g., using a low bond adhesive, and the like, which may be released or otherwise overcome when thecartridge 16 is advanced into an introducer sheath, as described further below. - In an exemplary embodiment, shown in
FIG. 2B , thesleeve 50 may be formed from an outerannular body 53 defining theproximal portion 52, and a section oftubing 55 at least partially received within theannular portion 53, e.g., defining thedistal portion 54. The components of thesleeve 50 may be made from the same or different materials, e.g., plastic, metal, or composite materials. For example, thetubing 55 may be formed from substantially rigid plastic, such as polyimide, and theannular body 53 may be formed from polyether block amide (PEBAX), polyurethane, silicone, or other relatively soft durometer materials. The components may be attached to one another, e.g., by bonding with adhesive, ultrasonic welding, fusing, melting, and the like. - As best seen in
FIG. 2B , anannular portion 53 a of theannular body 53 and thetubing 55 together define thelumen 56 that extends through thesleeve 50. Thelumen 56 may be sized to allow thesleeve 50 to slide over the tubular member 20 (not shown, see, e.g.,FIGS. 1A-2A ), e.g., while providing a slight interference. For example, theannular portion 53 a adjacent thetubing 55 may have an inner diameter slightly smaller than theinner diameter 55 a of thetubing 55, such that, when thesleeve 50 is directed proximally over the tubular member 20 (e.g., when thetubular member 20 is advanced distally relative to the sleeve 50), the soft durometer material of theannular portion 53 a may bunch up slightly, thereby expanding the size of thelumen 56 and reducing frictional interference between thesleeve 50 and thetubular member 20. Conversely, if thesleeve 50 is directed distally over the tubular member 20 (or thetubular member 20 is directed proximally relative to the sleeve 50), theannular portion 53 a surrounding thelumen 56 may stretch slightly, thereby reducing the size of thelumen 56 within theannular portion 53 a and increasing frictional interference between theannular portion 53 a of thesleeve 50 and thetubular member 20. In this manner, thesleeve 50 may slide freely proximally while being substantially prevented from sliding distally over thetubular member 20. - Returning to
FIGS. 1A and 1B , the positioningmember 14 generally includes anelongate member 40 including a proximal end 42 (not shown, see, e.g.,FIG. 3B ), adistal end 44, and an occlusion orpositioning element 46 on thedistal end 44. Thepositioning element 46 may be an expandable member, such as a balloon, a wire mesh structure, an expandable frame, and the like. Thepositioning element 46 may be selectively expandable, e.g., using a source of inflation media, a pull wire, and/or other actuator (not shown), operable from theproximal end 42 of the positioningmember 14. - For example, as shown, the positioning element may be a
balloon 46, and the positioningmember 14 may include atubular body 40 including a lumen (not shown) extending between the proximal and distal ends 42, 44 and communicating with an interior of theballoon 46. In this embodiment, the positioningmember 14 may include a source of inflation media, e.g., a syringe (not shown), that may be coupled to ahousing 48 on the proximal end 142 of the positioningmember 14. Optionally, the positioningmember 14 may include an internal pull wire (not shown) that causes theballoon 46 to shorten during expansion and extend during collapse. Exemplary embodiments of positioningmembers 14 including balloons that may be used are disclosed in co-pending application Ser. Nos. 10/454,362, filed Jun. 4, 2003, published as US 2004/0249342, 11/112,877, filed Apr. 22, 2005, published as US 2006/0253072, and 11/112/971, filed Apr. 22, 2005, and published international application WO 2006/115904. The entire disclosures of these references are expressly incorporated by reference herein. - Alternatively, the positioning element may be biased to an enlarged condition, but may be compressed to a contracted condition, e.g., by an overlying sleeve or other constraint (not shown). The constraint may be removed to expose the positioning element, allowing the expandable element to automatically expand to the enlarged condition. Additional information on expandable structures that may be provided on the positioning
member 14 may be found in U.S. Pat. Nos. 6,238,412, 6,635,068, and 6,890.343, and in co-pending application Ser. No. 10/975,205, filed Oct. 27, 2004. The entire disclosures of these references are expressly incorporated herein by reference. - Turning to
FIGS. 5A-5B , theapparatus 10 may be used to position and deliver thesealant 2 within a puncture, e.g., extra-vascularly just above or otherwise adjacent to an arteriotomy in a blood vessel or other body lumen communicating with a puncture, as described further elsewhere herein. In one embodiment, as shown inFIG. 3A , the cartridge 16 (along with theadvancer member 30 andsealant 2 within the tubular member 20) may be initially provided on theproximal end 42 of the positioningmember 14. For example, thehousing 48 on the positioningmember 14 and thehub 23 on thecartridge 16 may be initially connected to one another, e.g., using one or morereleasable detents FIG. 4A . - As shown in
FIG. 3B , thecartridge 16 may be slidable distally along the positioningmember 14, e.g., by disconnecting thehub 23 from thehousing 48, and then advancing thecartridge 16, e.g., until thedistal end 24 of thetubular member 20 is disposed adjacent thepositioning element 46. For example, thedetents hub 23 is advanced away from thehousing 48 with sufficient force. Alternatively, one of thehub 23 andhousing 48 may include an actuator or lock that may be activated (not shown) to separate thedetents cartridge 16 to be advanced relative to the positioningmember 14. - Optionally, the
cartridge 16 and/or positioningmember 14 may include cooperating features that limit distal movement of thecartridge 16 relative to the positioningmember 14. For example, as shown inFIG. 4B , thehub 23 of thecartridge 16 may include apocket 23 b and the positioningmember 14 may include a detent orother feature 41 a that may be received within thepocket 23 b when thecartridge 16 is advanced to a distal position. Optionally, thehandle 23 of thecartridge 16 may include a window or other opening (not shown) through which thepocket 23 b may be seen, e.g., to allow a user to visually confirm when the detent 41 has been fully received in thepocket 23 b. - The
detent 41 a may be provided on the outer surface of theelongate member 40 at a predetermined location between the proximal and distal ends 42, 44 such that thedistal end 24 of thetubular member 20 is spaced apart from thepositioning element 46 by a predetermined distance, e.g., providing between about two and five millimeters (2-5 mm) clearance between thedistal end 24 and thepositioning element 46. Alternatively, thedetent 41 a may be provided at a predetermined location such that thedistal end 24 of the tubular member may be jammed or otherwise extend into thepositioning element 46, e.g., by zero to two millimeters (0-2 mm). - The
detent 41 a may be a raised feature formed or attached to theelongate member 40 at the predetermined location. For example, the detent may be a proximal end of a section of tubing, e.g., heat shrink tubing, a collar, or other sleeve (not shown) attached around theelongate member 40, e.g., by bonding with adhesive, heat shrinking, ultrasonic welding, fusing, crimping, and the like. Alternatively, as shown, thedetent 41 a may overmolded or otherwise formed directly on theelongate member 40, as desired. - In addition or alternatively, the positioning
member 14 and/oradvancer member 30 may include one or more elements that engage when thecartridge 16 reaches a predetermined location when advanced along the positioningmember 14, e.g., to limit subsequent proximal movement of theadvancer member 30 relative to the positioningmember 14 when thetubular member 20 is subsequently retracted. For example, the positioningmember 14 may include a reduced diameter region (not shown) at a predetermined location, e.g., by providing a larger tube around a smaller inner tube or by machining, etching, or otherwise removing a portion of the tubular body of the positioningmember 14 distal to the reduced region. The larger tube may extend from the proximal end of the positioningmember 14 to the desired location for the detent, or may simply be a relatively short sleeve or other member (not shown) attached around or to the positioningmember 14 at the desired location, e.g., to provide a first ratchet or detent that theadvancer member 30 may pass over freely in the distal direction but not subsequently move proximally. - The
advancer member 30 may include a living hinge, tab, or other element 37 (also not shown) on theproximal end 32 that may pass freely over the reduced regions, ratchets, and/or other detents on the positioningmember 14, yet may be unable to pass proximally back over the reduced region. For example, as shown inFIG. 4B , the positioningmember 14 may include a ring, tab, or other raised element, e.g., a first and a second raised element orother detent advancer member 30 may include a corresponding element (also not shown) that may allow distal advancement but prevent proximal retraction once the advancermember 30 is advanced a predetermined distance. - The
first detent 41 a may be provided at a predetermined location on the positioningmember 14, e.g., a predetermined distance from thepositioning element 46 that substantially corresponds to a length of theadvancer member 30. As the cartridge 16 (and consequently the advancer member 30) is advanced over the positioningmember 14, e.g., until thesealant 2 is disposed adjacent thepositioning element 46, theelement 37 on theadvancer member 30 may pass freely over thefirst detent 41 a, as best seen inFIG. 4B . Thereafter, theelement 37 may prevent theadvancer member 30 from being retracted again past thefirst detent 41 a, e.g., due to a blunt edge of theelement 37 abutting the abrupt distal edge of thefirst detent 41 a. Thus, when thetubular member 20 is retracted after theadvancer member 30 has passed entirely over thefirst detent 41 a, theelement 37 may prevent theadvancer member 30 from retracting with thetubular member 20. Optionally, as shown inFIG. 4B , a second ratchet ordetent 41 b (shown in phantom) may be provided on the positioningmember 14 distal to thefirst detent 41 a, e.g., over which theadvancer member 30 may be advanced further, e.g., during compression of thesealant 2 after deployment, as described further below. Thesecond detent 41 b may be another tube or other feature (not shown) attached to or formed on the positioningmember 14, e.g., that provides a blunt distal edge. - In addition or alternatively, one or more markers may be provided on the
apparatus 10, e.g., to identify when components are located at one or more desired positions or otherwise to facilitate use of theapparatus 10. For example, as shown inFIG. 5A , the positioningmember 14 may include one or more markers at predetermined locations on theelongate member 40. Such markers may provide visual confirmation when thecartridge 16 has been advanced to a desired distal position, e.g., when the marker(s) 43 emerge from thehub 23 as thecartridge 16 is advanced over the positioningmember 14. - In addition or alternatively, as shown in
FIG. 5D , theadvancer member 30 may include one ormore markers 33 thereon, which may be visible when thecartridge 16 is advanced to a distal position and thetubular member 20 is retracted to expose thesealant 2. Thesemarkers 33 may also provide visual guides to inform the user when theadvancer member 30 is manipulated, e.g., advanced into a puncture to compress thesealant 2 therein, as described further below. - As best seen in
FIGS. 3A , 3B, and 5A-5D, theapparatus 10 is generally used in cooperation with anintroducer sheath 80. Theintroducer sheath 80 may part of a system or kit including theapparatus 10 or may be an independent device. Generally, theintroducer sheath 80 includes aproximal end 82, adistal end 84 sized for insertion into apuncture 90 through tissue, and alumen 86 extending between the proximal and distal ends 82, 84. Theintroducer sheath 80 may be formed from a substantially rigid, semi-rigid, and/or flexible tubular body including ahub 83 on theproximal end 82. Theintroducer sheath 80 may have sufficient length to extend from a patient's skin through any intervening tissue into a blood vessel or other body lumen, e.g., having a length between about ten centimeters and twenty centimeters (10-20 cm), and may have an outer diameter between about 1.6 millimeters and five millimeters (1.6-5 mm). Thedistal end 84 may be tapered and/or may include a substantially atraumatic distal tip 85 for facilitating advancement through a puncture. - The
introducer sheath 80 may be formed using known materials and/or methods, e.g., plastic with the tubular body andhub 83 substantially permanently connected together, e.g., using an interference fit, one or more mating connectors (not shown), bonding with adhesive, ultrasonic welding, and the like. Thehub 83 generally includes one or more seals, e.g., one or more hemostatic seals (not shown) therein, which may prevent flow of blood or other fluids out of thehub 83 from thelumen 86, yet accommodate insertion of one or more instruments into thelumen 26, such as the positioningmember 14 and/orcartridge 16. Optionally, as shown, thehub 83 may include aside port 89 communicating with thelumen 86, e.g., for coupling a source of saline or other fluid (not shown) to thehub 83. - Turning to
FIGS. 5A-5D , an exemplary method is shown for sealing apuncture 90, e.g., using theapparatus 10 to deliver asealant 2, e.g., to achieve hemostasis within thepuncture 90. Generally, thepuncture 90 extends from a patient'sskin 92 through interveningtissue 96, e.g., to abody lumen 94. In an exemplary embodiment, thepuncture 90 may be a percutaneous puncture communicating with ablood vessel 94, such as a femoral artery, carotid artery, and the like. - In an exemplary method, the
puncture 90 may be created using known procedures, e.g., using a needle, guidewire, one or more dilators, and the like (not shown). Anintroducer sheath 80 may be advanced through thepuncture 90 into thevessel 94, e.g., over a guide wire placed through thepuncture 90 into thevessel 94. Theintroducer sheath 80 may provide access into thevessel 92 for one or more instruments (not shown), e.g., to allow one or more diagnostic and/or interventional procedures to be performed via thevessel 94. Upon completing the procedure(s) via thevessel 94, any such instrument(s) may be removed from thepuncture 90, leaving theintroducer sheath 80 extending through thepuncture 90 into thevessel 94. - With reference to
FIG. 5A , the positioningmember 14 may be introduced into and/or through thelumen 46 of theintroducer sheath 80, e.g., with theexpandable positioning element 46 in a collapsed condition. Thecartridge 16, along with thesealant 2 andadvancer member 30, may be provided initially on theproximal end 42 of the positioningmember 40, e.g., as shown inFIG. 3A . Thus, thedistal end 24 of thetubular member 20 may initially be located outside thepuncture 90 when the positioningmember 40 is advanced into thepuncture 90. - Still referring to
FIG. 5A , thedistal end 44 of the positioning member 140 may be inserted through the puncture 90 (via the introducer sheath 80) and into thevessel 94. Once thepositioning element 46 is disposed within thevessel 94, i.e., beyond thedistal end 84 of theintroducer sheath 80, thepositioning element 46 may be expanded to an enlarged condition, as shown. After expanding thepositioning element 46, the positioningmember 40 may be at least partially withdrawn until thepositioning element 46 contacts the wall of thevessel 94, e.g., to substantially seal thevessel 94 from thepuncture 90. - In an exemplary method, this may involve a two-step process (although it may be completed in a single substantially continuous action). First, with the
positioning element 46 expanded within thevessel 94, the positioningmember 14 may be withdrawn until thepositioning element 46 contacts thedistal end 84 of theintroducer sheath 80, which may provide a first tactile feedback to the user (i.e., that thepositioning element 46 has contacted theintroducer sheath 80, e.g., based upon the increased weight and/or resistance to proximal movement). The positioningmember 14 may be withdrawn further until thepositioning element 46 contacts the wall of thevessel 94 and resists further withdrawal, thereby providing a second tactile feedback. Theintroducer sheath 80 may be pulled proximally by thepositioning element 46 as the positioningmember 14 is withdrawn, e.g., until thedistal end 84 of theintroducer sheath 80 is withdrawn from thevessel 94 into thepuncture 90, as shown inFIG. 5A . - Proximal tension may be applied and/or maintained on the positioning
member 14 to hold thepositioning element 46 against the wall of thevessel 94, e.g., to seal thepuncture 90 from thevessel 94 and/or prevent further removal of the positioningmember 14. The proximal tension may be maintained manually or using a tensioner device (not shown) to provide temporary hemostasis, e.g., during the subsequent steps. Exemplary tension devices are disclosed in co-pending application Ser. No. 10/806,952, filed Mar. 22, 2004, the entire disclosure of which is expressly incorporated herein by reference. - Turning to
FIGS. 3B and 5B , the cartridge 16 (carrying the sealant 2) may be advanced distally over the positioningmember 14 into thepuncture 90. For example,FIGS. 3A and 3B show thecartridge 16, carrying thesleeve 50 over thedistal end 24 of thetubular member 20, being advanced distally over the positioningmember 14 towards theintroducer sheath 80. As thecartridge 16 is advanced, thesleeve 50 may contact theintroducer sheath 80, which may prevent further advancement of thesleeve 50. For example, thedistal portion 54 of thesleeve 50 may at least partially enter thehub 83 of theintroducer sheath 80 and theproximal portion 52 of thesleeve 50 may abut thehub 83, as shown inFIGS. 5B and 5C , thereby preventing further advancement of thesleeve 50. If thesleeve 50 is releasably attached to thetubular member 20, advancement of thecartridge 16 to this point may release thesleeve 50 from thetubular member 20. - The
cartridge 16 may be further advanced into theintroducer sheath 80 toward thepositioning element 46, whereupon thesleeve 50 may remain substantially stationary relative to theintroducer sheath 80 and, consequently, slide proximally over thetubular member 20. Thus, thedistal end 24 of thetubular member 20 may exit thedistal portion 54 of thesleeve 50 and enter theintroducer sheath lumen 86. Optionally, thedistal portion 54 of thesleeve 50 may have sufficient length to at least partially open the valve(s) within theintroducer sheath hub 83, e.g., to facilitate thedistal end 24 of thetubular member 20 being advanced into theintroducer sheath lumen 86. Thus, thesleeve 50 may protect the slitteddistal tip 25 of thetubular member 20 until thedistal tip 25 passes into thehub 83 and/orlumen 86 of theintroducer sheath 80. - The
cartridge 16 may be advanced until a component of thecartridge 16 encounters a stop on the positioningmember 14, thereby preventing further advancement of thecartridge 16 and/or spacing the sealant 2 a predetermined distance from thepositioning element 46, e.g., about zero to five millimeters (0-5 mm) from thepositioning element 46 or zero to two millimeters (0-2 mm) into or beyond the positioningmember 14. For example, as shown inFIG. 4B , thecartridge 16 may be advanced until thedetent 41 a on the positioningmember 14 enters therecess 23 b in thecartridge hub 23. Alternatively, if the cooperating features 31, 23 b are omitted, thecartridge 16 may be advanced into theintroducer sheath 80 until thedistal end 24 contacts the expanded positioning element 46 (not shown), which may provide tactile feedback that thecartridge 16 has been advanced sufficiently, or thesealant 2 is otherwise positioned within thepuncture 90. - Thereafter, as shown in
FIG. 5D , thetubular member 20 of thecartridge 16 may be retracted, e.g., by pulling proximally on thehub 83 of theintroducer sheath 80, to withdrawn theintroducer sheath 80 andtubular member 20 from thepuncture 90 and expose thesealant 2 within the puncture beyond the introducer sheathdistal end 84. Optionally, thesleeve 50 may include one or more locking elements (not shown) that may couple theintroducer sheath 80 to thesleeve 50, similar to the embodiments disclosed in application Ser. No. 11/864,835, filed Sep. 28, 2007, and published as U.S. Publication No. 2009/0088793, the entire disclosure of which is expressly incorporated by reference herein. Thus, in this alternative, if the user pulls proximally on thesleeve 50 rather than theintroducer sheath 80, theintroducer sheath 80 andtubular member 20 may still be withdrawn together from thepuncture 90. - As the
tubular member 20 is retracted, theadvancer member 30 may prevent substantial proximal movement of thesealant 2, thereby exposing thesealant 2 within thepuncture 90, as shown inFIG. 5D . For example, as described above, as thecartridge 16 is advanced, the feature(s) 37 on theproximal end 32 of theadvancer member 30 may pass over the reduced region orfirst detent 41 a of the positioningmember 14, as shown inFIG. 4B , thereby preventing subsequent proximal withdrawal of theadvancer member 30 relative to the positioningmember 14. Thus, when thecartridge 16 is then refracted, theelement 37 on theadvancer member 30 may abut the blunt distal edge of the reduced region orfirst detent 41 a, thereby preventing substantial proximal movement of theadvancer member 30, and thesealant 2 adjacent thedistal end 34 of theadvancer member 30. - When the
sealant 2 is exposed within thepuncture 90, thesealant 2 may be exposed to blood and/or other body fluids within thepuncture 90. This exposure may cause thesealant 2 to absorb fluid and/or otherwise expand within thepuncture 90, e.g., to provide hemostasis. If desired, once thesealant 2 is exposed within thepuncture 90, theadvancer member 30 may be advanced to compress or tamp thesealant 2, e.g., against thepositioning element 46. Optionally, theadvancer member 30 may include one ormore markers 33, e.g., on or adjacent theproximal end 32, and theadvancer member 30 may be advanced into the puncture 90 a desired distance, which may be confirmed by monitoring themarkers 33. In addition or alternatively, as shown inFIG. 4B , the positioningmember 14 may include asecond detent 41 b over which theadvancer member 30 may pass when advanced a predetermined distance. Thesecond detent 41 b may provide an audible confirmation that theadvancer member 30 has been advanced the predetermined distance (in addition or instead of the visible confirmation provided by the markers 33). In addition, thesecond detent 41 b may ensure that theadvancer member 30 is not subsequently withdrawn once advanced the predetermined distance. - Once the
sealant 2 has been exposed for sufficient time and/or tamped by theadvancer member 30, thepositioning element 46 may be collapsed, and the positioningmember 14 withdrawn from thevessel 94 andpuncture 90, e.g., pulling the collapsedpositioning element 46 through thesealant 2 andadvancer member 30. Theadvancer member 30 may be maintained substantially stationary during withdrawal of the positioningmember 14, e.g., to prevent migration and/or dislodgment of thesealant 2 within thepuncture 90. Once the positioningmember 14 is completely removed, theadvancer member 30 may be removed from thepuncture 90, leaving thesealant 2 within thepuncture 90. - Optionally, after removing the positioning
member 14, liquid hydrogel or other sealing compound, or other material may be delivered into thepuncture 90, e.g., above and/or around thesealant 2, to assist in achieving hemostasis. For example, such material may be delivered via thelumen 36 of theadvancer member 30 and/or by introducing another delivery device (not shown) into thepuncture 90, e.g., after removing theadvancer member 30. - While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.
Claims (24)
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US18/059,808 Pending US20230338015A1 (en) | 2011-05-11 | 2022-11-29 | Apparatus and methods for sealing a vascular puncture |
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US18/059,808 Pending US20230338015A1 (en) | 2011-05-11 | 2022-11-29 | Apparatus and methods for sealing a vascular puncture |
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Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2827938A4 (en) * | 2012-03-23 | 2016-05-25 | Access Closure Inc | Apparatus and methods for sealing a vascular puncture |
US9757105B2 (en) | 2012-03-23 | 2017-09-12 | Accessclosure, Inc. | Apparatus and methods for sealing a vascular puncture |
US9782156B2 (en) | 2015-09-28 | 2017-10-10 | M-V Arterica AB | Vascular closure device |
TWI635840B (en) * | 2016-08-30 | 2018-09-21 | 周佳蓉 | Vascular puncture sealing device |
US10245012B2 (en) | 2012-03-23 | 2019-04-02 | Access Closure, Inc. | Apparatus and methods for sealing a vascular puncture |
JP2020185400A (en) * | 2014-11-14 | 2020-11-19 | アクセスクロージャー,インク. | Closure system for closing arteriotomy |
US11179145B2 (en) | 2017-11-16 | 2021-11-23 | M-V Arterica AB | Collapsible tube for hemostasis |
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US11938288B2 (en) | 2019-11-19 | 2024-03-26 | Arterica Inc. | Vascular closure devices and methods |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
USD865166S1 (en) | 2015-11-13 | 2019-10-29 | Access Closure, Inc. | Sheath adapter |
USD847988S1 (en) | 2015-11-13 | 2019-05-07 | Access Closure, Inc. | Handle grip |
USD843573S1 (en) | 2015-11-13 | 2019-03-19 | Access Closure, Inc. | Vascular closure apparatus |
EP3717050A4 (en) * | 2017-11-28 | 2021-08-04 | Pneumonix Medical, Inc. | Apparatus and method to seal a tissue tract |
USD935611S1 (en) | 2018-12-10 | 2021-11-09 | Pneumonix Medical, Inc. | Tissue tract sealant device |
Citations (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4654137A (en) * | 1985-04-15 | 1987-03-31 | Vaughan Daniel J | Multicompartmented cell with freely-extendible tubular membrane |
US6270484B1 (en) * | 1999-02-17 | 2001-08-07 | Inbae Yoon | Safety penetrating instrument with expandible portion and method of penetrating anatomical cavity |
US6527734B2 (en) * | 1998-05-01 | 2003-03-04 | Sub-Q, Inc. | System and method for facilitating hemostasis of blood vessel punctures with absorbable sponge |
US6540735B1 (en) * | 2000-05-12 | 2003-04-01 | Sub-Q, Inc. | System and method for facilitating hemostasis of blood vessel punctures with absorbable sponge |
US6818008B1 (en) * | 1992-01-07 | 2004-11-16 | Cch Associates, Inc. | Percutaneous puncture sealing method |
US20040267308A1 (en) * | 2003-06-04 | 2004-12-30 | Accessclosure, Inc. | Auto-retraction apparatus and methods for sealing a vascular puncture |
US20050085852A1 (en) * | 2003-10-15 | 2005-04-21 | Theresa Ditter | Vascular sealing device with locking hub |
US6899727B2 (en) * | 2001-01-22 | 2005-05-31 | Gore Enterprise Holdings, Inc. | Deployment system for intraluminal devices |
US20060015171A1 (en) * | 2004-07-16 | 2006-01-19 | Armstrong Joseph R | Deployment system for intraluminal devices |
US20060034930A1 (en) * | 1998-08-14 | 2006-02-16 | Accessclosure, Inc. | Apparatus and methods for sealing a vascular puncture |
US20060100664A1 (en) * | 2004-11-05 | 2006-05-11 | Accessclosure, Inc. | Apparatus and methods for sealing a vascular puncture |
US20070135837A1 (en) * | 2005-12-13 | 2007-06-14 | Cardiva Medical, Inc. | Drug eluting vascular closure devices and methods |
US20090088793A1 (en) * | 2007-09-28 | 2009-04-02 | Accessclosure, Inc. | Apparatus and methods for sealing a vascular puncture |
US20090254110A1 (en) * | 2008-04-04 | 2009-10-08 | Accessclosure, Inc. | Apparatus and Methods for Sealing a Vascular Puncture |
US20100168767A1 (en) * | 2008-06-30 | 2010-07-01 | Cardiva Medical, Inc. | Apparatus and methods for delivering hemostatic materials for blood vessel closure |
US20100168789A1 (en) * | 2008-11-12 | 2010-07-01 | Bagaoisan Celso J | Apparatus and methods for sealing a vascular puncture |
US20100234726A1 (en) * | 1998-12-24 | 2010-09-16 | Sirimanne D Laksen | Device and method for safe location and marking of a biopsy cavity |
US7806903B2 (en) * | 2007-06-13 | 2010-10-05 | Hoya Corporation | Clipping instrument for an endoscopic surgical device |
US8128654B2 (en) * | 2003-06-04 | 2012-03-06 | Accessclosure, Inc. | Apparatus and methods for sealing a vascular puncture |
US20120089177A1 (en) * | 2010-10-08 | 2012-04-12 | St. Jude Medical Puerto Rico LLC. | Cam driven compaction tube for vascular closure device |
US8382798B2 (en) * | 2006-09-13 | 2013-02-26 | Accessclosure, Inc. | Apparatus for sealing a vascular puncture |
Family Cites Families (168)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2115492A (en) | 1936-04-27 | 1938-04-26 | Searle & Co | Pharmaceutical products adapted for injection into the human body |
US2365039A (en) | 1941-09-09 | 1944-12-12 | Case Pomeroy & Company | Method of treating oil wells |
US3002742A (en) | 1960-04-20 | 1961-10-03 | Troy Leonard | Vehicle suspension system |
US3765419A (en) | 1971-05-14 | 1973-10-16 | Int Paper Co | Amylose acetate |
US4002173A (en) | 1974-07-23 | 1977-01-11 | International Paper Company | Diester crosslinked polyglucan hydrogels and reticulated sponges thereof |
US4327709A (en) | 1978-03-06 | 1982-05-04 | Datascope Corp. | Apparatus and method for the percutaneous introduction of intra-aortic balloons into the human body |
US4260077A (en) | 1979-10-04 | 1981-04-07 | Aelco Corporation | Dual separable dispenser |
US4362150A (en) | 1980-09-10 | 1982-12-07 | Kontron Cardiovascular Inc. | Percutaneous intra-aortic balloon apparatus |
EP0058497B1 (en) | 1981-02-05 | 1985-08-28 | Nippon Oil Co. Ltd. | Process for preparing a hydrogel |
US4734097A (en) | 1981-09-25 | 1988-03-29 | Nippon Oil Company, Ltd. | Medical material of polyvinyl alcohol and process of making |
JPS5930881A (en) | 1982-08-13 | 1984-02-18 | Nippon Oil Co Ltd | Manufacture of low-temperature insulating gel |
US4540404A (en) | 1983-01-19 | 1985-09-10 | Datascope Corp. | Balloon catheter with intrinsic introducer for percutaneous insertion into a blood vessel over a guide wire, and method of use |
JPS6144825A (en) | 1984-08-09 | 1986-03-04 | Unitika Ltd | Hemostatic agent |
DE3641593A1 (en) | 1985-12-06 | 1987-06-11 | Fuji Photo Film Co Ltd | DOUBLE PIPETTE DEVICE |
US4738658A (en) | 1986-09-19 | 1988-04-19 | Aries Medical Incorporated | Tapered hemostatic device for use in conjunction with a catheter for alleviating blood leakage and method for using same |
US4890612A (en) | 1987-02-17 | 1990-01-02 | Kensey Nash Corporation | Device for sealing percutaneous puncture in a vessel |
USRE34866E (en) | 1987-02-17 | 1995-02-21 | Kensey Nash Corporation | Device for sealing percutaneous puncture in a vessel |
US4852568A (en) | 1987-02-17 | 1989-08-01 | Kensey Nash Corporation | Method and apparatus for sealing an opening in tissue of a living being |
US4838864A (en) | 1987-11-13 | 1989-06-13 | Mansfield Scientific, Inc. | Pressure controller |
US4838280A (en) | 1988-05-26 | 1989-06-13 | Haaga John R | Hemostatic sheath for a biopsy needle and method of use |
US5643464A (en) | 1988-11-21 | 1997-07-01 | Collagen Corporation | Process for preparing a sterile, dry crosslinking agent |
US5550187A (en) | 1988-11-21 | 1996-08-27 | Collagen Corporation | Method of preparing crosslinked biomaterial compositions for use in tissue augmentation |
US5087246A (en) | 1988-12-29 | 1992-02-11 | C. R. Bard, Inc. | Dilation catheter with fluted balloon |
NL8901350A (en) | 1989-05-29 | 1990-12-17 | Wouter Matthijs Muijs Van De M | CLOSURE ASSEMBLY. |
US5487897A (en) | 1989-07-24 | 1996-01-30 | Atrix Laboratories, Inc. | Biodegradable implant precursor |
US5104375A (en) | 1989-10-16 | 1992-04-14 | Johnson & Johnson Medical, Inc. | Locking holder for a pair of syringes and method of use |
CA2122041A1 (en) | 1989-12-04 | 1993-04-29 | Kenneth Kensey | Plug device for sealing openings and method of use |
US5061274A (en) | 1989-12-04 | 1991-10-29 | Kensey Nash Corporation | Plug device for sealing openings and method of use |
EP0476178A1 (en) | 1990-09-21 | 1992-03-25 | Bioplex Medical B.V. | Device for placing styptic material on perforated blood vessels |
US5391183A (en) | 1990-09-21 | 1995-02-21 | Datascope Investment Corp | Device and method sealing puncture wounds |
US5192300A (en) | 1990-10-01 | 1993-03-09 | Quinton Instrument Company | Insertion assembly and method of inserting a vessel plug into the body of a patient |
US5108421A (en) | 1990-10-01 | 1992-04-28 | Quinton Instrument Company | Insertion assembly and method of inserting a vessel plug into the body of a patient |
US6325789B1 (en) | 1990-12-27 | 2001-12-04 | Datascope Investment Corporation | Device and method for sealing puncture wounds |
US5221259A (en) | 1990-12-27 | 1993-06-22 | Novoste Corporation | Wound treating device and method of using same |
US5419765A (en) | 1990-12-27 | 1995-05-30 | Novoste Corporation | Wound treating device and method for treating wounds |
NL9101051A (en) | 1991-06-18 | 1993-01-18 | Ashridge Ag | CLOSING DEVICE FOR A VESSEL OR THE LIKE. |
US5104389A (en) | 1991-06-27 | 1992-04-14 | Cordis Corporation | Medical instrument valve with foam partition member having vapor permeable skin |
US5766151A (en) | 1991-07-16 | 1998-06-16 | Heartport, Inc. | Endovascular system for arresting the heart |
US5259835A (en) | 1991-08-29 | 1993-11-09 | Tri-Point Medical L.P. | Wound closure means and method using flowable adhesive |
US5290310A (en) | 1991-10-30 | 1994-03-01 | Howmedica, Inc. | Hemostatic implant introducer |
US5676689A (en) | 1991-11-08 | 1997-10-14 | Kensey Nash Corporation | Hemostatic puncture closure system including vessel location device and method of use |
US5222974A (en) | 1991-11-08 | 1993-06-29 | Kensey Nash Corporation | Hemostatic puncture closure system and method of use |
US5282827A (en) | 1991-11-08 | 1994-02-01 | Kensey Nash Corporation | Hemostatic puncture closure system and method of use |
US5258042A (en) | 1991-12-16 | 1993-11-02 | Henry Ford Health System | Intravascular hydrogel implant |
US6056768A (en) | 1992-01-07 | 2000-05-02 | Cates; Christopher U. | Blood vessel sealing system |
US6699261B1 (en) | 1992-01-07 | 2004-03-02 | Cch Associates, Inc. | Blood vessel sealing system |
GB9206504D0 (en) | 1992-03-25 | 1992-05-06 | Jevco Ltd | Heteromorphic sponges as wound implants |
US5326350A (en) | 1992-05-11 | 1994-07-05 | Li Shu Tung | Soft tissue closure systems |
US6350274B1 (en) | 1992-05-11 | 2002-02-26 | Regen Biologics, Inc. | Soft tissue closure systems |
US5413571A (en) | 1992-07-16 | 1995-05-09 | Sherwood Medical Company | Device for sealing hemostatic incisions |
US5443481A (en) | 1992-07-27 | 1995-08-22 | Lee; Benjamin I. | Methods and device for percutaneous sealing of arterial puncture sites |
US5292332A (en) | 1992-07-27 | 1994-03-08 | Lee Benjamin I | Methods and device for percutanceous sealing of arterial puncture sites |
AU664913B2 (en) | 1992-08-13 | 1995-12-07 | Implico B.V. | A hydrogel composition and methods of making it |
US5306254A (en) | 1992-10-01 | 1994-04-26 | Kensey Nash Corporation | Vessel position locating device and method of use |
US5334216A (en) | 1992-12-10 | 1994-08-02 | Howmedica Inc. | Hemostatic plug |
US5514158A (en) | 1992-12-28 | 1996-05-07 | Kanesaka; Nozomu | Sealing device for a percutaneous puncture |
US5320639A (en) | 1993-03-12 | 1994-06-14 | Meadox Medicals, Inc. | Vascular plug delivery system |
US5584815A (en) | 1993-04-02 | 1996-12-17 | Eli Lilly And Company | Multi-cartridge medication injection device |
US5868778A (en) | 1995-10-27 | 1999-02-09 | Vascular Solutions, Inc. | Vascular sealing apparatus and method |
US6017359A (en) | 1993-05-25 | 2000-01-25 | Vascular Solutions, Inc. | Vascular sealing apparatus |
US5951583A (en) | 1993-05-25 | 1999-09-14 | Vascular Solutions, Inc. | Thrombin and collagen procoagulant and process for making the same |
US5626601A (en) | 1995-10-27 | 1997-05-06 | Gary Gershony | Vascular sealing apparatus and method |
US5383896A (en) | 1993-05-25 | 1995-01-24 | Gershony; Gary | Vascular sealing device |
US5601603A (en) | 1993-06-16 | 1997-02-11 | White Spot Ag | Use of and process for the introduction of fibrin sealant into a puncture channel |
US5409703A (en) | 1993-06-24 | 1995-04-25 | Carrington Laboratories, Inc. | Dried hydrogel from hydrophilic-hygroscopic polymer |
US5725551A (en) | 1993-07-26 | 1998-03-10 | Myers; Gene | Method and apparatus for arteriotomy closure |
US5486195A (en) | 1993-07-26 | 1996-01-23 | Myers; Gene | Method and apparatus for arteriotomy closure |
US5403291A (en) | 1993-08-02 | 1995-04-04 | Quinton Instrument Company | Catheter with elongated side holes |
US5431639A (en) | 1993-08-12 | 1995-07-11 | Boston Scientific Corporation | Treating wounds caused by medical procedures |
WO1995008289A2 (en) | 1993-09-16 | 1995-03-30 | Scimed Life Systems, Inc. | Percutaneous repair of cardiovascular anomalies and repair compositions |
US5843124A (en) | 1993-09-28 | 1998-12-01 | Hemodynamics, Inc. | Surface opening adhesive sealer |
US5383899A (en) | 1993-09-28 | 1995-01-24 | Hammerslag; Julius G. | Method of using a surface opening adhesive sealer |
AT400675B (en) | 1993-10-18 | 1996-02-26 | Immuno Ag | SYRINGE SET FOR STORAGE AND APPLICATION OF A MULTI-COMPONENT MATERIAL, SYRINGE DEVICE AND ACTUATING DEVICE THEREFOR, AND METHOD FOR PRODUCING A FILLED, STERILE SYRINGE DEVICE |
US5370660A (en) | 1993-11-01 | 1994-12-06 | Cordis Corporation | Apparatus and method for delivering a vessel plug into the body of a patient |
US5437292A (en) | 1993-11-19 | 1995-08-01 | Bioseal, Llc | Method for sealing blood vessel puncture sites |
US5728122A (en) | 1994-01-18 | 1998-03-17 | Datascope Investment Corp. | Guide wire with releaseable barb anchor |
US5795331A (en) | 1994-01-24 | 1998-08-18 | Micro Therapeutics, Inc. | Balloon catheter for occluding aneurysms of branch vessels |
PT754032E (en) | 1994-04-08 | 2002-05-31 | Atrix Lab Inc | LIQUID COMPOSITIONS FOR DIFFUSE |
WO1995029729A1 (en) | 1994-04-29 | 1995-11-09 | Boston Scientific Corporation | Novel micro occlusion balloon catheter |
WO1995032671A1 (en) | 1994-06-01 | 1995-12-07 | Perclose, Inc. | Method and device for providing vascular hemostasis |
US6033401A (en) | 1997-03-12 | 2000-03-07 | Advanced Closure Systems, Inc. | Vascular sealing device with microwave antenna |
US6302898B1 (en) | 1994-06-24 | 2001-10-16 | Advanced Closure Systems, Inc. | Devices for sealing punctures in body vessels |
US5709934A (en) | 1994-11-22 | 1998-01-20 | Tissue Engineering, Inc. | Bipolymer foams having extracellular matrix particulates |
EP0716833A3 (en) | 1994-12-14 | 1997-01-29 | Global Therapeutics Inc | Method and apparatus for sealing a body site |
JPH10512470A (en) | 1995-01-18 | 1998-12-02 | メドケム プロダクツ,インコーポレーテッド | Apparatus and method for applying a hemostatic agent to tissue |
US5580923A (en) | 1995-03-14 | 1996-12-03 | Collagen Corporation | Anti-adhesion films and compositions for medical use |
US5900245A (en) | 1996-03-22 | 1999-05-04 | Focal, Inc. | Compliant tissue sealants |
US5785679A (en) | 1995-07-19 | 1998-07-28 | Endotex Interventional Systems, Inc. | Methods and apparatus for treating aneurysms and arterio-venous fistulas |
US5731368A (en) | 1995-09-01 | 1998-03-24 | Union Carbide Chemicals & Plastics Technology Corporation | Aoueous vinyl polymer dispersions |
US5752974A (en) | 1995-12-18 | 1998-05-19 | Collagen Corporation | Injectable or implantable biomaterials for filling or blocking lumens and voids of the body |
DE19612628A1 (en) | 1996-03-29 | 1997-10-02 | Hoechst Ag | Process for the production of porous, hydrophilic, highly swellable hydrogels |
US5728132A (en) | 1996-04-08 | 1998-03-17 | Tricardia, L.L.C. | Self-sealing vascular access device |
US5728133A (en) | 1996-07-09 | 1998-03-17 | Cardiologics, L.L.C. | Anchoring device and method for sealing percutaneous punctures in vessels |
US5836970A (en) | 1996-08-02 | 1998-11-17 | The Kendall Company | Hemostatic wound dressing |
US6063061A (en) | 1996-08-27 | 2000-05-16 | Fusion Medical Technologies, Inc. | Fragmented polymeric compositions and methods for their use |
WO1998012274A1 (en) | 1996-09-23 | 1998-03-26 | Chandrashekar Pathak | Methods and devices for preparing protein concentrates |
US6566406B1 (en) | 1998-12-04 | 2003-05-20 | Incept, Llc | Biocompatible crosslinked polymers |
US7009034B2 (en) | 1996-09-23 | 2006-03-07 | Incept, Llc | Biocompatible crosslinked polymers |
WO1998030141A2 (en) | 1997-01-09 | 1998-07-16 | Cohesion Technologies, Inc. | Devices for tissue repair and methods for preparation and use thereof |
US5718916A (en) | 1997-02-03 | 1998-02-17 | Scherr; George H. | Alginate foam products |
US6045570A (en) | 1997-02-11 | 2000-04-04 | Biointerventional Corporation | Biological sealant mixture and system for use in percutaneous occlusion of puncture sites and tracts in the human body and method |
US6056769A (en) | 1997-02-11 | 2000-05-02 | Biointerventional Corporation | Expansile device for use in blood vessels and tracts in the body and tension application device for use therewith and method |
US5782860A (en) | 1997-02-11 | 1998-07-21 | Biointerventional Corporation | Closure device for percutaneous occlusion of puncture sites and tracts in the human body and method |
US6464712B1 (en) | 1997-02-11 | 2002-10-15 | Biointerventional Corporation | Expansile device for use in blood vessels and tracts in the body and method |
US5951589A (en) | 1997-02-11 | 1999-09-14 | Biointerventional Corporation | Expansile device for use in blood vessels and tracts in the body and tension application device for use therewith and method |
DE59710286D1 (en) | 1997-03-10 | 2003-07-17 | Disetronic Licensing Ag | DEVICE FOR DISPENSING LIQUIDS |
US6371975B2 (en) | 1998-11-06 | 2002-04-16 | Neomend, Inc. | Compositions, systems, and methods for creating in situ, chemically cross-linked, mechanical barriers |
US6271278B1 (en) | 1997-05-13 | 2001-08-07 | Purdue Research Foundation | Hydrogel composites and superporous hydrogel composites having fast swelling, high mechanical strength, and superabsorbent properties |
ZA987019B (en) | 1997-08-06 | 1999-06-04 | Focal Inc | Hemostatic tissue sealants |
WO1999022646A1 (en) | 1997-10-31 | 1999-05-14 | Sherwood Services Ag | Hemostatic puncture closure device |
WO1999023952A1 (en) | 1997-11-12 | 1999-05-20 | William Dubrul | Biological passageway occlusion removal |
US6635068B1 (en) | 1998-02-10 | 2003-10-21 | Artemis Medical, Inc. | Occlusion, anchoring, tensioning and flow direction apparatus and methods for use |
US5948829A (en) | 1997-11-25 | 1999-09-07 | Kimberly-Clark Worldwide, Inc. | Process for preparing an absorbent foam |
US5941847A (en) | 1998-02-06 | 1999-08-24 | Medela Holding Ag | Breast shield with vacuum isolation element |
US6626861B1 (en) | 1998-04-22 | 2003-09-30 | Applied Medical Resources | Balloon catheter apparatus and method |
US6610026B2 (en) | 1998-05-01 | 2003-08-26 | Sub-Q, Inc. | Method of hydrating a sponge material for delivery to a body |
US6048358A (en) | 1998-07-13 | 2000-04-11 | Barak; Shlomo | Method and apparatus for hemostasis following arterial catheterization |
US6613070B2 (en) | 1998-08-04 | 2003-09-02 | Baxter International Inc. | System and method for sealing vascular penetrations with hemostatic gels |
US20020015724A1 (en) | 1998-08-10 | 2002-02-07 | Chunlin Yang | Collagen type i and type iii hemostatic compositions for use as a vascular sealant and wound dressing |
US6514534B1 (en) | 1998-08-14 | 2003-02-04 | Incept Llc | Methods for forming regional tissue adherent barriers and drug delivery systems |
JP4159254B2 (en) | 1998-08-14 | 2008-10-01 | インセプト エルエルシー | Method and apparatus for in situ formation of hydrogels |
US6703047B2 (en) | 2001-02-02 | 2004-03-09 | Incept Llc | Dehydrated hydrogel precursor-based, tissue adherent compositions and methods of use |
US6818018B1 (en) | 1998-08-14 | 2004-11-16 | Incept Llc | In situ polymerizable hydrogels |
US6152943A (en) | 1998-08-14 | 2000-11-28 | Incept Llc | Methods and apparatus for intraluminal deposition of hydrogels |
US6605294B2 (en) | 1998-08-14 | 2003-08-12 | Incept Llc | Methods of using in situ hydration of hydrogel articles for sealing or augmentation of tissue or vessels |
US6179862B1 (en) | 1998-08-14 | 2001-01-30 | Incept Llc | Methods and apparatus for in situ formation of hydrogels |
US6458147B1 (en) | 1998-11-06 | 2002-10-01 | Neomend, Inc. | Compositions, systems, and methods for arresting or controlling bleeding or fluid leakage in body tissue |
US6994686B2 (en) | 1998-08-26 | 2006-02-07 | Neomend, Inc. | Systems for applying cross-linked mechanical barriers |
GB9819461D0 (en) | 1998-09-08 | 1998-10-28 | Univ Strathclyde | Hydrogels |
AUPP633798A0 (en) | 1998-10-02 | 1998-10-29 | White, Geoffrey H. | Device for the occlusion of a puncture in a bodily duct |
US6022361A (en) | 1998-10-09 | 2000-02-08 | Biointerventional Corporation | Device for introducing and polymerizing polymeric biomaterials in the human body and method |
US6830756B2 (en) | 1998-11-06 | 2004-12-14 | Neomend, Inc. | Systems, methods, and compositions for achieving closure of vascular puncture sites |
US6949114B2 (en) | 1998-11-06 | 2005-09-27 | Neomend, Inc. | Systems, methods, and compositions for achieving closure of vascular puncture sites |
WO2000030553A1 (en) | 1998-11-20 | 2000-06-02 | Medical Industries Corp. | Hemostatic agent inserting device |
SE518736C2 (en) | 1999-08-30 | 2002-11-12 | Sca Hygiene Prod Ab | Absorbent, open-celled foam material with good liquid storage capacity and absorbent structure in an absorbent article |
US6984219B2 (en) | 1999-09-23 | 2006-01-10 | Mark Ashby | Depth and puncture control for blood vessel hemostasis system |
US6780197B2 (en) * | 2000-01-05 | 2004-08-24 | Integrated Vascular Systems, Inc. | Apparatus and methods for delivering a vascular closure device to a body lumen |
US6942674B2 (en) | 2000-01-05 | 2005-09-13 | Integrated Vascular Systems, Inc. | Apparatus and methods for delivering a closure device |
US7842068B2 (en) * | 2000-12-07 | 2010-11-30 | Integrated Vascular Systems, Inc. | Apparatus and methods for providing tactile feedback while delivering a closure device |
US20020120228A1 (en) | 2000-06-08 | 2002-08-29 | Yuh-Fun Maa | Powder compositions |
WO2002005865A2 (en) | 2000-07-14 | 2002-01-24 | Sub-Q, Inc. | Sheath-mounted arterial plug delivery device |
US6890342B2 (en) | 2000-08-02 | 2005-05-10 | Loma Linda University | Method and apparatus for closing vascular puncture using hemostatic material |
US6626918B1 (en) | 2000-10-06 | 2003-09-30 | Medical Technology Group | Apparatus and methods for positioning a vascular sheath |
US6890343B2 (en) | 2000-12-14 | 2005-05-10 | Ensure Medical, Inc. | Plug with detachable guidewire element and methods for use |
US6537569B2 (en) | 2001-02-14 | 2003-03-25 | Microvention, Inc. | Radiation cross-linked hydrogels |
US6569185B2 (en) | 2001-02-15 | 2003-05-27 | Scimed Life Systems Inc | Continuous infusion technique for arterial sealing |
US6608117B1 (en) | 2001-05-11 | 2003-08-19 | Nanosystems Research Inc. | Methods for the preparation of cellular hydrogels |
US6863680B2 (en) | 2001-11-08 | 2005-03-08 | Sub-Q, Inc. | System and method for delivering hemostasis promoting material to a blood vessel puncture site by fluid pressure |
AU2002310364B2 (en) | 2001-06-08 | 2006-02-23 | Morris Innovative Research, Inc. | Method and apparatus for sealing access |
AU2001100654B4 (en) | 2001-07-03 | 2002-05-09 | Ann Margaret Duncan | A template to assist the process of circular sewing, embroidery and the like |
KR100947468B1 (en) | 2001-07-26 | 2010-03-17 | 쿠크 바이오텍, 인코포레이티드 | Vessel closure member and delivery apparatus |
US6592608B2 (en) | 2001-12-07 | 2003-07-15 | Biopsy Sciences, Llc | Bioabsorbable sealant |
FR2838748B1 (en) | 2002-04-17 | 2004-07-09 | Urgo Laboratoires | NEW HYDROPHILIC THERMAL MELT ADHESIVE COMPOSITIONS |
WO2003089506A1 (en) | 2002-04-22 | 2003-10-30 | Purdue Research Foundation | Hydrogels having enhanced elasticity and mechanical strength properties |
US6936033B2 (en) | 2002-06-14 | 2005-08-30 | Medtronic, Inc. | Multiple ratio fluid dispenser |
ATE266969T1 (en) | 2002-06-12 | 2004-06-15 | Radi Medical Systems | LOCKING DEVICE |
US20040147016A1 (en) | 2002-09-30 | 2004-07-29 | Rowley Jonathan A. | Programmable scaffold and methods for making and using the same |
US7955353B1 (en) | 2002-11-04 | 2011-06-07 | Sub-Q, Inc. | Dissolvable closure device |
US8709038B2 (en) | 2002-12-20 | 2014-04-29 | Boston Scientific Scimed, Inc. | Puncture hole sealing device |
US6863924B2 (en) | 2002-12-23 | 2005-03-08 | Kimberly-Clark Worldwide, Inc. | Method of making an absorbent composite |
US7008442B2 (en) | 2003-01-20 | 2006-03-07 | Medtronic Vascular, Inc. | Vascular sealant delivery device and sheath introducer and method |
US20070060950A1 (en) | 2003-12-24 | 2007-03-15 | Farhad Khosravi | Apparatus and methods for delivering sealing materials during a percutaneous procedure to facilitate hemostasis |
US7806856B2 (en) | 2005-04-22 | 2010-10-05 | Accessclosure, Inc. | Apparatus and method for temporary hemostasis |
US8002742B2 (en) | 2005-04-22 | 2011-08-23 | Accessclosure, Inc. | Apparatus and methods for sealing a puncture in tissue |
US8088144B2 (en) | 2005-05-04 | 2012-01-03 | Ensure Medical, Inc. | Locator and closure device and method of use |
US8795709B2 (en) | 2006-03-29 | 2014-08-05 | Incept Llc | Superabsorbent, freeze dried hydrogels for medical applications |
US7850710B2 (en) | 2006-05-23 | 2010-12-14 | St. Jude Medical Puerto Rico Llc | Puncture closure apparatuses, sealing plugs, and related methods |
WO2010027693A2 (en) | 2008-08-26 | 2010-03-11 | Killion Douglas P | Method and system for sealing percutaneous punctures |
-
2011
- 2011-05-11 US US13/105,822 patent/US9386968B2/en active Active
-
2016
- 2016-06-13 US US15/180,941 patent/US10314567B2/en active Active
-
2019
- 2019-05-21 US US16/418,095 patent/US11534150B2/en active Active
-
2022
- 2022-11-29 US US18/059,808 patent/US20230338015A1/en active Pending
Patent Citations (25)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4654137A (en) * | 1985-04-15 | 1987-03-31 | Vaughan Daniel J | Multicompartmented cell with freely-extendible tubular membrane |
US6818008B1 (en) * | 1992-01-07 | 2004-11-16 | Cch Associates, Inc. | Percutaneous puncture sealing method |
US6527734B2 (en) * | 1998-05-01 | 2003-03-04 | Sub-Q, Inc. | System and method for facilitating hemostasis of blood vessel punctures with absorbable sponge |
US20060034930A1 (en) * | 1998-08-14 | 2006-02-16 | Accessclosure, Inc. | Apparatus and methods for sealing a vascular puncture |
US20100234726A1 (en) * | 1998-12-24 | 2010-09-16 | Sirimanne D Laksen | Device and method for safe location and marking of a biopsy cavity |
US6270484B1 (en) * | 1999-02-17 | 2001-08-07 | Inbae Yoon | Safety penetrating instrument with expandible portion and method of penetrating anatomical cavity |
US6540735B1 (en) * | 2000-05-12 | 2003-04-01 | Sub-Q, Inc. | System and method for facilitating hemostasis of blood vessel punctures with absorbable sponge |
US6899727B2 (en) * | 2001-01-22 | 2005-05-31 | Gore Enterprise Holdings, Inc. | Deployment system for intraluminal devices |
US20040267308A1 (en) * | 2003-06-04 | 2004-12-30 | Accessclosure, Inc. | Auto-retraction apparatus and methods for sealing a vascular puncture |
US8128654B2 (en) * | 2003-06-04 | 2012-03-06 | Accessclosure, Inc. | Apparatus and methods for sealing a vascular puncture |
US20050085852A1 (en) * | 2003-10-15 | 2005-04-21 | Theresa Ditter | Vascular sealing device with locking hub |
US20060015171A1 (en) * | 2004-07-16 | 2006-01-19 | Armstrong Joseph R | Deployment system for intraluminal devices |
US20080097521A1 (en) * | 2004-11-05 | 2008-04-24 | Accessclosure, Inc. | Apparatus and methods for sealing a vascular puncture |
US20060100664A1 (en) * | 2004-11-05 | 2006-05-11 | Accessclosure, Inc. | Apparatus and methods for sealing a vascular puncture |
US20070135837A1 (en) * | 2005-12-13 | 2007-06-14 | Cardiva Medical, Inc. | Drug eluting vascular closure devices and methods |
US8382798B2 (en) * | 2006-09-13 | 2013-02-26 | Accessclosure, Inc. | Apparatus for sealing a vascular puncture |
US8382797B2 (en) * | 2006-09-13 | 2013-02-26 | Accessclosure, Inc. | Methods for sealing a vascular puncture |
US7806903B2 (en) * | 2007-06-13 | 2010-10-05 | Hoya Corporation | Clipping instrument for an endoscopic surgical device |
US20090088793A1 (en) * | 2007-09-28 | 2009-04-02 | Accessclosure, Inc. | Apparatus and methods for sealing a vascular puncture |
US7993367B2 (en) * | 2007-09-28 | 2011-08-09 | Accessclosure, Inc. | Apparatus and methods for sealing a vascular puncture |
US20090254110A1 (en) * | 2008-04-04 | 2009-10-08 | Accessclosure, Inc. | Apparatus and Methods for Sealing a Vascular Puncture |
US8029533B2 (en) * | 2008-04-04 | 2011-10-04 | Accessclosure, Inc. | Apparatus and methods for sealing a vascular puncture |
US20100168767A1 (en) * | 2008-06-30 | 2010-07-01 | Cardiva Medical, Inc. | Apparatus and methods for delivering hemostatic materials for blood vessel closure |
US20100168789A1 (en) * | 2008-11-12 | 2010-07-01 | Bagaoisan Celso J | Apparatus and methods for sealing a vascular puncture |
US20120089177A1 (en) * | 2010-10-08 | 2012-04-12 | St. Jude Medical Puerto Rico LLC. | Cam driven compaction tube for vascular closure device |
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US11534150B2 (en) | 2022-12-27 |
US20190336115A1 (en) | 2019-11-07 |
US9386968B2 (en) | 2016-07-12 |
US20160296218A1 (en) | 2016-10-13 |
US10314567B2 (en) | 2019-06-11 |
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